R533354 Senior Specialist, Regulatory Affairs
4 weeks 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
4 weeks 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
1 week ago
Santolan, Metro Manila, Philippines Icon Executive Asia Full time ₱1,200,000 - ₱3,600,000 per yearJob Title: Regulatory Affairs & Quality Manager Work Location: Libis, Quezon City and Santolan, Pasig City (Onsite) Work Schedule: Monday to Friday | 8:00 AM – 5:30 PM Target Onboarding Date: ASAP Employment Type: Full-Time | OnsiteJob Overview:We are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) Manager to oversee and implement...
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Regulatory Affairs
2 weeks ago
Libis, Metro Manila, Philippines Viventis Search Asia Full time ₱2,000,000 - ₱2,500,000 per yearOur client, a fast-growing distribution company who provides quality, affordable personal care and health products, is looking for a Regulatory Affairs & Quality Assurance Manager. He/She will oversee and manage all quality control activities to ensure products or services meet established standards and regulatory requirements. This includes developing...
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Regulatory Affairs
3 weeks ago
Manila, Philippines Fonterra Full timeRegulatory Affairs & FSQ Manager - Philippines Fonterra Manila, National Capital Region, Philippines Overview Reporting to the Senior FSQ & Regulatory Affairs Manager (SEA), the Regulatory Affairs & FSQ Manager is responsible for ensuring regulatory compliance and food safety and quality (FSQ) assurance for products and operations in their market. This role...
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Regulatory Affairs Director
2 weeks ago
Manila, Philippines KSearch Asia Consulting, Inc. Full timeJOB DESCRIPTION Lead all regulatory activities in the Philippines including product registrations, renewals, variations, and post-approval requirements for pharmaceutical, biologic, and medical device products. Ensure compliance with FDA regulations and guidelines, including timely submissions and responses to regulatory queries. Build and maintain strong...
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Regulatory Affairs Manager
3 days ago
Ortigas, Metro Manila, Philippines WELLBEST GLOBAL CORP. Full time ₱900,000 - ₱1,200,000 per yearBachelor's degree in a relevant scientific field (biology, chemistry, pharmacy, etc.)Master's degree or professional certification in Regulatory Affairs (preferred)Deep knowledge of regulatory requirements within the specific industry (pharmaceuticals, medical devices, food, cosmetics)Understanding of global regulatory landscapes and their...
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Regulatory Affairs Manager
1 week ago
Manila, Philippines GlaxoSmithKline Full timeSite Name: Finance Center Building Posted Date: Nov 5 2025 Job Title: Regulatory Affairs Manager Position Summary Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our...
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Regulatory Affairs Associate
3 days ago
Manila, National Capital Region, Philippines &you Full time ₱600,000 - ₱1,200,000 per yearWHO we are:A telehealth platform focusing on transformative, stigmatized health issues. Our goal is to address Southeast Asia's most overlooked and misunderstood health concerns.WHERE and HOW you can work:Our head office is located in the heart of Taguig City, at BGC, a vibrant business and lifestyle hub. We offer our employees the benefit of flexi-time,...
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Regulatory Affairs Officer
3 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...
