R533354 Senior Specialist, Regulatory Affairs
2 days ago
Job Description Responsibilities: The Senior Specialist is responsible for all Regulatory Affairs submission requirements for their assigned product portfolio as applicable. He/she is the regulatory contact with local stakeholders and headquarters (HQ) and is the direct contact for health authority submission specific topics.The Senior Specialist also acts as the regulatory relevant License Holder for the company (eg. License To Operate).The Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and drug safety oversight.The Senior Specialist is also responsible for other activities (as delegated/assigned by their manager).Assists in development of product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with management oversight.Assists in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers including but not limited to variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards.Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirementsActs in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues.Supports local PV audits and inspections including readiness activities and response to findings/observations.Participates in and supports audits of contractual partners/ vendors as necessary.May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality RA data and evaluate processes for potential improvement in efficiency and effectiveness.Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.Supports training of local company staff, distributors, vendors, business partners including training documentationContributes in the maintenance of regulatory licenses including, but not limited to, product licenses, import and distribution of pharmaceuticals and medical device.May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Head Quality Assurance to avoid supply constraints and ensure constant audit-readiness.Liaises with the local business units to keep them apprised of safety activities and provide strategic decisions (i.e. product launches, clinical trials) with management oversight.As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.
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R533354 Senior Specialist, Regulatory Affairs
8 hours ago
Manila, Philippines half the sky Full timeJob Description Responsibilities: The Senior Specialist is responsible for all Regulatory Affairs submission requirements for their assigned product portfolio as applicable. He/she is the regulatory contact with local stakeholders and headquarters (HQ) and is the direct contact for health authority submission specific topics. The Senior Specialist also acts...
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Manila, National Capital Region, Philippines Half the sky Full time ₱500,000 - ₱1,500,000 per yearJob DescriptionResponsibilities:The Senior Specialist is responsible for all Regulatory Affairs submission requirements for their assigned product portfolio as applicable. He/she is the regulatory contact with local stakeholders and headquarters (HQ) and is the direct contact for health authority submission specific topics.The Senior Specialist also...
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Regulatory Affairs Officer
5 days ago
Bonifacio Global, Metro Manila, Philippines SRS Life Sciences Full time ₱1,200,000 - ₱2,500,000 per yearJOB PURPOSEWe are seeking a experienced Regulatory Affairs Officer with comprehensive knowledge of regulatory processes and at least 5 years of experience in preparing and managing drug dossiers.As Regulatory Affairs Officer, you will play a critical role in ensuring that our Drug, Medical Device, Food Supplements and Cosmetic products adhere to all...
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Regulatory Affair Pharmacist
7 days ago
Ortigas, Metro Manila, Philippines Elixir Pharma Inc Full time $60,000 - $80,000 per yearElixir Pharma Inc. is looking for a Regulatory Pharmacist to strengthen our compliance and regulatory affairs team. The role involves handling the preparation and submission of regulatory documents for drugs, food supplements, and cosmetics, ensuring full compliance with FDA requirements. This is an excellent opportunity for a licensed pharmacist with 3–5...
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Senior Public Affairs Manager
5 days ago
Manila, National Capital Region, Philippines Lalamove Full time ₱1,200,000 - ₱2,400,000 per yearLalamove is disrupting the logistics industry by connecting customers and drivers directly through our technology. We offer customers a lightning fast and convenient way to book delivery and moving services whether they are at their home, at work or on the go. People talk about O2O, we live it Currently, Lalamove is a leading global on-demand delivery...
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Senior Public Affairs Manager
7 days ago
Manila, National Capital Region, Philippines Lalamove Full time ₱1,200,000 - ₱2,400,000 per yearLalamoveis disrupting the logistics industry by connecting customers and drivers directly through our technology. We offer customers a lightning fast and convenient way to book delivery and moving services whether they are at their home, at work or on the go. People talk about O2O, we live it Currently, Lalamove is a leading global on-demand delivery...
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Regulatory, Legal
5 days ago
Bagumbayan, Metro Manila, Philippines Oleo-Fats Inc. (OFI) Full timeJob SummaryRegulatory, Legal & Statutory Specialist is responsible for overseeing and monitoring the organization's compliance with relevant laws, regulatory, and statutory requirements. This role ensures adherence to management system certification, stays up to date with regulatory changes, and communicates required actions to maintain continuous...
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Legal & Corporate Affairs Manager - Pharma
3 weeks ago
, Metro Manila, Philippines Michael Page Full timeOpportunity for personal and professional growth! Join a leading global pharmaceutical company! About Our Client A global healthcare organization with a strong local presence that continues to advance therapeutic innovation and patient care through strategic partnerships and science-driven solutions. Job Description Lead and manage compliance initiatives,...
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Medical Affairs Manager
1 week ago
Manila, Philippines SciGen Pte. Ltd. Full timeMedical Affairs Manager Responsible for Scigen’s medical strategy and scientific communication. This includes overseeing the development and execution of TA’s scientific strategy, serving as a bridge between the company and external medical experts, ensuring compliance with regulations, and managing medical information. The role requires strong...
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Medical Affairs Manager
7 days ago
Manila, National Capital Region, Philippines Menarini Asia-Pacific Full time ₱2,000,000 - ₱2,500,000 per yearThe Medical Affairs Manager will provide strong support to Medical Affairs Director in managing Medical Affairs operations related to compliance to medical ethical & regulatory standards.Key Areas of Responsibilities:Compliance – Promotions Approval: Reviews promotional materials to ensure compliance with regulations and guidelines, and claims are...
