Scientific & Regulatory Affairs Manager

Regulatory Affairs Manager

Taguig, National Capital Region ₱ - ₱ Y Celltrion Global Safety Data Center Inc.

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Job Description

Perform duplicate searches of cases booked in initially from the database. Perform data analysis on safety reports, coding all medical history, events, drugs /procedures/indications, and laboratory tests. Perform initial assessment of reports for listedness/expectedness and causality. Write and edit safety narratives of cases. Ensure that both the internal and regulatory timelines are met for both serious and non-serious adverse event reports submissions. Attend internal, pharmacovigilance, and project-specific training. Mentor new team members as assigned by Team Lead. Can be cross trained to provide support to other CGSDCI workflow for business continuity. Ensure that delivery and quality standards per CGSDCI KPIs are met. Support team and company initiatives and programs. Perform other ad-hoc tasks/duties as assigned by Team Lead.

General Requirement:

• License Requirement: Must hold a valid PRC license.
• Work Experience: Minimum 1 year of relevant work experience in Life Science/Healthcare fields. Work in Drug Safety within CRO is an advantage.
• Internship Eligibility: Former Interns of Celltrion are welcome to apply.
• Work Arrangement: Six (6) months onsite duty with Housing Support to eligible employees. Work-from-Home upon regularization (1x RTO/month)
• Work Schedule: Must be available to work Monday to Friday or Tuesday to Saturday after training certification.
• Shift Schedule: With fixed schedule (e.g. 6AM-3PM, 8AM-5PM and 12NN to 9PM) based on assigned team.
• Start Date: Ready to hire on the 1st business day of each month.

Your resume submitted to us will be reviewed by CGSDCI and Celltrion, Inc., a parent company located in Korea, for evaluation purposes on a need-to-know basis. We are committed to protecting and respecting your personal data and it will be treated in accordance with our internal data protection policies.

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0

Regulatory Affairs Officer

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About the role. Reporting to the Head of Regulatory Affairs, this full-time Regulatory Affairs Officer position at Square Pharmaceutical, Inc" is a crucial role within the company's Science & Technology team. Based in Carmona Cavite, this role will be responsible for ensuring Square Pharmaceutical's products meet all relevant regulatory requirements and guidelines.

What you'll be doing

• Prepare and submit regulatory applications and documentation to governing bodies such as the FDA and EMA
• Monitor changes in regulations and guidelines, and advise the business on the impact and required actions
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
• Lead regulatory inspections and audits, and manage any resulting corrective actions
• Build and maintain strong relationships with key regulatory authorities
• Contribute to the development and implementation of the company's regulatory strategy

What we're looking for

• In-depth knowledge of global regulatory requirements and guidelines for pharmaceutical products
• Excellent written and verbal communication skills, with the ability to translate complex regulatory information
• Strong project management and problem-solving skills, with the ability to work independently
• Graduate of BS Pharmacy (licensed or not welcome to apply)

What we offer

• Dynamic, collaborative work environment with supportive colleagues

About us

Square Pharmaceutical, Inc" is a pharmaceutical company dedicated to developing and manufacturing high-quality medications. With a strong focus on innovation and quality, we are committed to advancing the standards of healthcare through our diverse portfolio of products and solutions.

If this role sounds like the perfect next step in your career, we encourage you to apply now.

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1

Regulatory Affairs Specialist

Posted 1 day ago

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MAIN PURPOSE OF ROLE

Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES

• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

QUALIFICATIONS

Experience/Background

Minimum 1 year

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2

Regulatory Affairs Assistant

Taguig, National Capital Region ₱ - ₱ Y Bandwell Pharmaceuticals Inc.

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Position Title: Business Development and Regulatory Affairs Assistant

Responsibilities:

Business Development

• Assist in providing scientific and medical information to help the Company create a product pipeline.
• Assist in conducting market and product research to identify new products and opportunities for the Company.
• Assist in sourcing of manufacturers and other suppliers needed for launching new products.

Regulatory Affairs

• Coordinates registration requirements with the suppliers.
• Assist and evaluates the requirements of Certificate of Product Registration (CPR) and other FDA authorizations.
• File, monitors and closely follow up applications with the FDA.
• Monitor and maintain the validity of CPR's, LTO's, and other permits.
• Register and maintain the the validity of trademarks with the Intellectual Property Office.
• Generate and maintain product barcodes.
• Request and monitor labeling exhaustion of all products.
• Assist in maintaining and keeping the records of all regulatory-related documents such as Agreements with suppliers, FDA Licenses for local suppliers, GMP Certificates for foreign and local suppliers, Adverse Drug Reaction Reports, Product Complaints, Product Recall, Batch Notifications (for antibiotics), Lot Release Certificates (for vaccines).
• Responsible for receiving complaints from customers through letter, email, or by hand.
• Provide related documents needed for hospital inclusion, institutions, special accounts, and others.
• Assist in reviewing and updating Standard Operating Procedures (SOP) and Risk Management Plan (RMP) yearly.
• Assist in reviewing marketing collaterals for approval.

Qualifications:

• Male/Female
• Graduate of Bachelor of Science in Pharmacy
• Registered Pharmacist
• With at least 2 years experience in any Pharmacy setting
• With technical and regulatory knowledge is an advantage
• Has good interpersonal skills
• Organized and attentive to detail

What we can offer:

• Very innovative and highly dynamic organization
• High achieving, driven, experienced team
• Competitive and above industry compensation package
• Fun and homelike work environment
• The chance to be part of a rapidly growing startup and the next success story

Benefits (upon hiring or regularization) :

• HMO
• Group Life Insurance
• Free Lunch
• VL & SL
• OPD Medical Reimbursement
• Optical Reimbursement
• Clothing Allowance / Company Uniform

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3

Regulatory Affairs Pharmacist

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Regulatory Affairs Pharmacist
ensures that the company complies with applicable FDA and other regulatory related government entities regulations on licenses, technical documents and product registrations. Sr. Regulatory Pharmacist is responsible for preparation, evaluation and submission of Initial application for Drugs, Food, Medical Devices and Cosmetics, PCPR and CLIDP renewals, GMP applications, LTO Inclusions and Variations. This is a desk-based role, involving the close study of scientific and legal documents.

Responsibilities

Responsible in ensuring the correctness and compliance of the documents per FDA Guidelines for the Initial Applications and Biologicals Drug Applications upon submission to FDA to merit an approval and secure a Certificate of Product Registration.

Ensures that approval and Certificate of Product Registration will be given for the Initial Registration of Food Initials, Medical Device Initials and Cosmetic Notifications.

Responsible for renewal and revalidation of Principal Certificate of Product Registration and Certificate of Listing of Identical Product and ensure that the documents are overflowing with quality to secure the approval from FDA.

Communicates Equivalence Evidence Study with the supplier, evaluates and prepares for submission. Makes sure that Bioequivalence Study Report meets the Criteria of ASEAN Guidelines, and the Biowaiver Study/Comparative Dissolution Profile meets the WHO Guidelines.

Responsible for variation/amendment applications of Certificate of Listing of Identical Product and Principal Certificate of Product Registration.

Qualifications

• Must be a licensed/registered Pharmacist
• Knows how to operate Microsoft Office (MS Word, Excel, Powerpoint, Outlook), and PDF (Nitro Pro, Adobe etc).
• Can check documents for grammar, spelling, and punctuation errors.
• Highly self-motivated, goal-oriented, and committed to pursuing a long-term career.
• Exceptionally well organized and strong work ethic.

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4

Regulatory Affairs Head

Taguig, National Capital Region ₱ - ₱ Y Starhub Distribution and Logistics Services, Inc.

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QUALIFICATIONS:

Graduate of Food Technology, Pharmacist or any related course. with at least 2 years experience in processing permits such as License to Operate (LTO) , FDA etc.

JOB DESCRIPTIONS:

• Process permits such as (LTO,FDA etc.)
• Conduct GMP audit/inspection for compliance
• Monitors defects, on hold and all product dispositions.
• Handles regulatory requirements set by client and government agency in relation to food safety issue.
• Ensure quality standards are being observed by conducting regular inspection.
• Performs other duties that may be assigned from time to time.
• Assist Regulatory for certification

Job Type: Full-time

• Company Christmas gift
• Health insurance
• Opportunities for promotion

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5

Manager - Regulatory Affairs

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Are you passionate about regulatory affairs in medical devices? If so, this opportunity could be for you Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare

As a Regulatory Affairs Manager at B. Braun you will play a critical role in ensuring the organization's compliance with regulatory requirements and facilitating the timely and successful registration and approval of medical products. The incumbent will manage regulatory submissions, communicate with regulatory agencies, and provide regulatory guidance and support to cross-functional teams. This role requires strong regulatory knowledge, project management skills, and the ability to navigate complex regulatory landscapes.

Your key responsibilities:

• Ensure the organization's compliance with regulatory requirements and facilitating the timely and successful registration of medical products.
• Manage regulatory submissions, communicate with regulatory agencies, and provide regulatory guidance and support to cross-functional teams. This role requires strong regulatory knowledge, project management skills, and the ability to address complex regulatory matters.
• Develop and implement regulatory strategies to support the registration, approval, and maintenance of medical B. Braun products in compliance with applicable regulations and guidelines.
• Continuously monitor the regulatory landscape (i.e., changes in regulatory requirements, standards, trends, etc.) assess any potential impact on the organization, and provide recommendations for compliance strategies and actions.
• Ensure compliance with regulatory requirements throughout the product lifecycle, including development, distribution, and post-market surveillance.
• Acts as the Local Safety Officer (LSO): Perform the designated tasks and responsibilities according to Global standards and local regulations.
• Communicate with regulatory agencies to facilitate the review and approval process, address questions or concerns, and obtain regulatory clearances or approvals.
• Coordinate and support product registration and approval activities, including the preparation and submission of regulatory dossiers, technical documents, and quality records, in accordance with local regulations and requirements.
• Serve as a regulatory subject matter expert and provide guidance and support to internal stakeholders on regulatory matters, including interpretation of regulations, standards, and guidelines.
• Provide regulatory training and education to internal stakeholders to enhance awareness and understanding of regulatory requirements, processes, and responsibilities.

What you will bring to the team:

• Bachelor's degree in a scientific, technical, or healthcare-related field required; Advanced degree preferred.
• Minimum of 5-7 years of experience in regulatory affairs in the pharmaceutical and medical device industry, with at least 3 years in a managerial or leadership role.
• Strong knowledge of regulatory requirements and guidelines, including FDA regulations, , and international regulatory requirements.
• Experienced in preparing and submitting regulatory filings, managing regulatory submissions, and interacting with regulatory agencies.
• Excellent project management, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Ability to analyze complex regulatory issues, develop innovative solutions, and drive regulatory strategies to achieve business objectives.
• Proficiency in regulatory affairs software, document management systems, and Microsoft Office Suite.

What sets B. Braun apart?
B. Braun is dedicated to protecting and improving global health. Established in the Philippines in 1985, it leverages over 185 years of innovation from its parent company, B. Braun Melsungen AG, which operates in 64+ countries. Initially focused on sutures and disposables, B. Braun Philippines has grown over 39 years to employ more than 800 sales and service professionals.

We now offer advanced dialysis treatments and a broad range of healthcare solutions, including infusion devices, surgical instruments, sutures, regional anaesthesia, haemodialysis machines, disposables, value-added drugs, and clinical nutrition, delivering comprehensive patient care across the country.

What can we offer you?

• Group Term life Insurance
• Medical and Optical Reimbursement
• Maternity assistance
• Training and development programs
• Engage in fun activities and team building events

What's next?

Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the first interview. We ask you to conduct two interviews, one in person and one remotely. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary

We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.

To find out more about our commitment to diversity click here

Check us out on Social Media
B. Braun Group LinkedIn

To find out more about B. Braun Philippines here

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6

Regulatory Affairs Associate

Taguig, National Capital Region ₱ - ₱ Y Philtech Inc.

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Job Description:

• Provide regulatory expertise on cross-functional project teams and ensure all consumer brands' packaging complies with federal, state, and local regulations. This involves daily interactions with marketing, graphic design, sourcing, and outside design agencies to ensure that all existing, new, and revised packaging graphics and placements comply with labeling regulations.
• Create Label copy with ingredient statements, nutrition facts, substantiating complex claims, and approving graphics and ensuring the accuracy of the regulatory information in Albertsons databases, on final artwork, and in specifications. This interaction is required from the beginning of the design process to review the final artwork before package production.
• Support the commercialization process and ensure the timely execution of regulatory-related tasks– including co-packer and self-manufactured product label copy review, claims substantiation, maintenance of Checklists, Consumer Brands Style Guide and SOPs. Provide input on nutrition labeling, defining new claim territories and managing packaging timelines.
• Facilitate content management for regulatory systems (Specright, Optiva, Genesis, Smart Label), ensuring accurate information and process are maintained in the systems.
• Require an excellent understanding and application of US labeling regulations (USDA, FDA, EPA) to assure the accuracy of ingredient statements, nutrition facts, allergen declarations and claims.
• Ability to think strategically as well as independently monitor, interpret and ensure compliance with US regulations today and into the future.

Job Qualifications:

• Food Service, Food Science, Dietician or Nutrition experience - Formal degree not required as direct experience can provide the necessary knowledge; BS/BA degree with focus on data mining and business analysis, or equivalent, is preferred.
• Minimum of 2 years of experience in technical data entry or administrative support, including document preparation and tracking, with a preference for compliance work within the retail industry.
• Proficiency with MS Office and technical data entry
• Experience in working directly with a technical functional group is preferred.
• Must have basic data entry skills with the ability to understand and work with technical information templates, documents, and data systems.
• Must have strong typing skills and be able to handle multiple ongoing projects simultaneously, managing own time to complete assignments within the allotted project timelines.
• Must be comfortable with asking questions and having direct discussions of project requirements with peers, supervisors, and product development personnel up to the VP level.
• Must be able to interface directly with product suppliers to obtain compliance with information requests and meet project timelines.
• Strong communication skills (verbal, email, and face-to-face) are required.

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7

Regulatory Affairs Pharmacist

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Role Description

This is a full-time on-site role for a Regulatory Affairs Pharmacist at DEEL CORPORATION located in Alabang, Muntinlupa City. The Regulatory Affairs Pharmacist will be responsible for ensuring regulatory compliance, understanding and implementing regulatory requirements, managing regulatory affairs, and utilizing pharmacy knowledge to support the company's operations.

Tasks

• Monitor the validity of License to Operate, Certificate of Product Registration, Certificate of Product Notification and all legal documents.
• Maintain and process the product registration and renewal of License to Operate, Certificate of Product Registration, Certificate of Product Notification and other related documents.
• Update all necessary documents for product registration and for government transactions.
• Coordinate with our principals for the required documents to be submitted to FDA.
• Communicate with the Marketing and Advertising team to ensure strict compliance with the guidelines and policies of the regulatory agency.
• Compile and maintain complete technical data of each product.
• Prepare, evaluate and submit documents for product registration to FDA.
• Monitor and follow up continuously on the application status of products filed for registration.
• Perform proper and timely documentation and submission of required technical information of the products to FDA for appropriate processing of certificates.
• Ensure that the company complies with the applicable government rules and regulations.
• Be updated on new regulations or changes.
• Facilitate back-end support team within its respective department (Sales & Administrative).
• Assure all inventory stocks are in a good storage area and properly labelled.
• Assist in the preparation of necessary documents for government transactions.
• Attend seminars and training to broaden regulatory knowledge.
• Provide relevant information to sales personnel regarding new updates, advisory and guidelines related to FDA and DOH concerns.
• Handle customer complaints, product return, product recall and counterfeit products. Provide necessary actions to resolve existing issues and problems.
• Maintain the availability and inventory of stocks.
• Maintain a good distribution record and good storage of the product.

Qualifications

• Degree in Pharmacy, with PRC License
• Experience in Regulatory Affairs and Pharmacy
• Excellent communication skills, organizational and technical skills
• Attention to detail and analytical skills
• Ability to interpret and implement regulatory guidelines

Job Type: Full-time

Pay: From Php30,000.00 per month

• Company events
• Promotion to permanent employee

Application Question(s):

• Are you comfortable working in an on-site setting?
• Are you comfortable commuting to this job's location (Alabang, Muntinlupa City)?

License/Certification:

• PRC License (Required)

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8

Regulatory Affairs Senior Specialist

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Job Description

The Regulatory Affairs Senior Specialist supports the preparation and submission of regulatory documents, ensuring compliance with local and international pharmaceutical regulations. The role involves liaising with regulatory authorities to ensure timely approvals and maintaining regulatory compliance for pharmaceutical products.

Technical Skills:

• Licensed Pharmacist
• At least 7 years of experience in Regulatory Affairs including liaising with regulatory authorities.
• With understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH).

Key Responsibilities:

1. Regulatory Submissions:

Prepare, compile, and submit product registration dossiers, renewals, and variations in accordance with regulatory requirements.

Liaise with regulatory authorities to follow up on submissions and address queries or deficiencies promptly.

2. Documentation Management:

Organize and maintain regulatory files, records, and databases to ensure accurate tracking of submissions and approvals.

Ensure all regulatory documentation is complete, accurate, and compliant with relevant guidelines.

3. Compliance Monitoring:

Monitor updates in regulatory requirements and guidelines and assist in implementing necessary changes.

Review labeling, packaging, and promotional materials to ensure regulatory compliance.

4. Cross-Functional Support:

Collaborate with internal teams (e.g., Quality, Manufacturing, Marketing) to gather required documents and data for regulatory purposes.

Provide regulatory support during product development and lifecycle management.

5. Communication with Authorities:

Serve as a primary contact for regulatory authorities, ensuring effective communication and addressing regulatory concerns.

Maintain strong working relationships with key stakeholders in regulatory agencies

Job Types: Full-time, Permanent, Fixed term

• Paid training

Education:

• Bachelorüs (Preferred)

License/Certification:

• Licensed Pharmacist (Required)

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