Regulatory Affairs Manager And Pharmacist

Regulatory Affairs Manager and Pharmacist

Posted today

Job Description

Key Duties and Responsibilities:

• Regulatory Submissions: Prepare, review, and submit product registration applications for medical devices, diagnostic reagents, and medical equipment to the Philippine FDA.
• Compliance Monitoring: Ensure that all products comply with the regulatory requirements of the Philippine FDA, including standards for safety, efficacy, and labeling of medical devices and machines.
• Product Documentation: Maintain and update technical documentation, product dossiers, and ensure timely submission of regulatory documents and reports.
• Liaison with FDA and Authorities: Serve as the primary point of contact with the Philippine FDA and other regulatory bodies to facilitate product approvals, renewals, and post-market surveillance activities.
• Regulatory Strategy: Develop and implement regulatory strategies to optimize registration timelines and ensure smooth market access for new and existing products.
• Cross-functional Collaboration: Work closely with the R&D, Quality Assurance, and Marketing teams to ensure all products meet regulatory requirements throughout their lifecycle.
• Training and Updates: Stay informed on changes in local and international regulations and provide regulatory training and updates to internal teams.

Skills and Qualifications:

• Licensed Pharmacist in the Philippines.
• Minimum of 5 to 10 years of experience in regulatory affairs, specifically with medical devices, reagents, or machines or in a similar industry.
• In-depth knowledge of Philippine FDA regulations related to medical devices, diagnostic reagents, and medical equipment.
• Strong understanding of product registration processes and post-market compliance.
• Excellent communication and interpersonal skills to liaise with regulatory bodies and internal teams.
• Detail-oriented, with strong organizational and project management abilities.

Job Type: Full-time

• Opportunities for promotion
• Paid toll fees
• Paid training
• Promotion to permanent employee

Ability to commute/relocate:

• San Juan (National Capital Region): Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Regulatory Affairs Manager: 5 years (Required)

License/Certification:

Willingness to travel:

• 75% (Preferred)

Posted today

Job Description

An RA plays a vital role in ensuring that company products are compliant with Regulatory Agencies' laws, guidelines and administrative orders being issued. The main focus is to ensure compliance, secure and attain regulatory approvals, keep well informed on all orders and guidelines from agencies, and advise the company on regulatory matters not only on product registrations, but also with other branches of government involved in launching products and supply chain.

The role of a RA Associate requires a deep understanding of regulatory requirements and policies. The ideal candidate should have good communication skills and extensive attention to detail.

Key Responsibilities:

• Interpretation and research: Knowledgeable on regulatory guidelines and procedures in renewal and initial application of product registrations, identify and investigate changes in policies, existing policies, and interpret them for the company.
• Submission and documentation: Manage and prepare regulatory documentation, labeling requirements, various reports from required studies (bio-efficacy, toxicity, etc.), and operate agency portals.
• Compliance and communication: Understand and adhere to relevant guidelines and regulations; interact with agency personnel; respond to communications and inquiries; monitor submissions updates.
• Advisory Role: Provide support and guide internal teams on regulatory requirements and rulings that may affect process flow.
• Maintenance and Monitoring: Track updates on new issuances and policies; stay informed about regulatory changes and keep the company informed.

Typical Tasks:

• Preparing and submitting regulatory filings, such as product registration applications (initial, renewals, variation).
• Knowledge of operating agency portals (e.g., FDA e-portal, promo permits, integration filing).
• Reviewing and ensuring accuracy of product labels for compliance submissions.
• Maintaining regulatory databases and tracking submissions.
• Participating in random inspections and audits by regulatory agencies; maintain readiness of files.
• Knowledge of implementing regulatory strategies.

Required Skills and Qualifications:

• Bachelor's degree in a relevant field (e.g., science, pharmacy, regulatory affairs).
• Strong knowledge of regulations and guidelines.
• Good communication and interpersonal skills.
• Attention to detail and strong organizational skills.
• Works independently and as a team player.
• Proficiency in relevant software and database systems.

Job Type: Full-time

• Additional leave
• Company Christmas gift
• Health insurance
• Life insurance
• Opportunities for promotion
• Paid training
• Promotion to permanent employee

Application Question(s):

• Are you amenable to work on-site?

Posted today

Job Description

Nature and Scope: The Quality and Regulatory Affairs (QARA) Officer will provide leadership in the quality and regulatory affairs function, ensuring compliance with regulatory requirements for the importation and distribution of products. The role involves authoring and refining process documentation and maintaining and monitoring the company's quality management system.

Key Responsibilities:

• Quality Assurance (QA): Develop, implement, and maintain the company's quality management system (QMS) in accordance with applicable standards and regulations. Conduct internal audits to ensure SOP and policy compliance.
• Regulatory Affairs (RA): Prepare, review, and submit regulatory documents and product registration applications to relevant authorities (e.g., FDA, PDEA, BOC).
• Documentation and Compliance: Maintain accurate documentation related to quality and regulatory affairs; ensure labels, packaging, and marketing materials comply with regulatory requirements.
• Cross-Functional Collaboration: Work with Sales & Marketing and Technical Group to provide regulatory support and ensure product compliance.

Job Requirements:

• Graduates in health professions such as Pharmacy, Nursing, Medical Technology, Dentistry, Radiology Technology, Medicine, Physical Therapy, or other allied sciences relevant to the devices distributed.
• Certification or training in Quality Management Systems (QMS), Good Warehousing Practices (GWP), or regulatory affairs.
• PRC License; Knowledge of local and international regulations (e.g., FDA, ISO 9001, ISO 13485, GWP, GDP).

Job Types: Full-time, Permanent

• Company Christmas gift
• Company events
• Health insurance
• Opportunities for promotion
• Paid training