Executive Search Firm Monroe Consulting Group Philippines is recruiting on behalf of a multinational pharmaceutical company. Our respected client is seeking an Regulatory Affairs and Quality Management Manager. The role will report to the Country Manager dotted line to the Regional and Global, and will handle 3 direct reports. Work setup is twice a week (2x) work from home and three times (3x) a week work onsite.
Key job responsibilities include:
- Acts as a liaison between the company and regulatory offices.
- Coordinates with Regional and Global Regulatory Affairs for strategic, ethical, efficient, and prompt compliance to local regulatory requirements.
- Reviews, analyzes, prepares and collates regulatory documents for new products/projects of all product groups according to current regulatory regulations (e.g. ASEAN Common Technical Documents/Requirements, ASEAN Common Submission Dossier Template and ASEAN Variation Guidelines, national guidelines).
- Gathers files and maintains electronic and hard copies of dossiers/correspondences for FDA submissions in the corresponding product files/binders.
- Monitors and facilitates in-process regulatory agency submissions Handles submission to FDA of all post approval variations.
- Coordinates, implements strategies and observes ethical standards for prompt renewal and acquisition of required permits, licenses, clearances and other regulatory requirements.
- Coordinates with Quality Assurance and manufacturing plant in artwork development of labeling materials in accordance with the local regulations(country specific requirements).
- Updates local and corporate regulatory databases for tracking product life cycle of all registrations including post-approval changes.
- Provides support to sales team on bidding requirements and product formulary inclusions in the Hospitals and Philippine National Formulary.
- Monitors regulatory agency and industry changes, trends and requirements in order to contribute effectively to product development and product strategies.
Deputy National Officer
- Assists the NSO to establish and maintain a local PV System including management of related documentation and ensures out-of-office availability.
- Acts as support to the NSO in Overseeing Patient Support Program/s (PSP) initiated by the company and ensure compliance according to Global System.
- Coordinates in handling and timely reporting of safety related issues (ADR) in accordance with the national laws and corporate guidelines.
- Secondary user of the COSI (Communication of Safety Information). Coordinates with the NSO on the timely submission of ADR and periodic safety update reports (PSUR) to the local health authorities.
- Provides support in training and updates on the regulations and processes to field (e.g. Medical Sales Representatives) and nonfield (e.g. office-based) personnel on a regular basis.
- Checks websites of the local health authorities for safety relevant information and participate in their training programs.
- Conducts literature search in accordance to SOPs. Safekeeps and maintains of and regulatory related documents and records.
- Responsible for ensuring Company's compliance with Company's Quality Management System and compliance directives.
- Overall in-charge of external and internal audits.
Key job qualifications include:
- Graduate of Pharmacy
- Licensed Pharmacist
- Multinational pharmaceutical experience is required
- Quality Management experience is a plus
- At least 5 years in a managerial role
- Open to work on a hybrid setup (3x a week onsite, 2x a week work from home)