Executive search firm Monroe Consulting Group Philippines is recruiting on behalf of a Pharmaceutical company that provides innovative health and wellness products. Our respected client is seeking for a Medical & Regulatory Affairs Manager who will oversees regulatory compliance and pharmacovigilance of the company. Responsibilities include ensuring compliance with regulations, overseeing marketing materials, managing product complaints, coordinating with stakeholders, budget formulation, and team performance management, including coaching and development initiatives.
Job responsibilities:
Regulatory and Compliance
-Ensures full compliance to regulations set by the Department of Health (DOH) on Electronic Drug Monitoring and the Food and Drug Administration (FDA) on the application, renewal and amendment of the following:
- License to Operate
- Certificate of Product Registration
- Product variation and changes
- Promo permit
- Other related documents
-Ensures constant coordination and assistance with all other business units.
Medico - Marketing Management
- Oversees the conduct of the comprehensive review of all marketing communication materials and product labels ensuring all messages are based on scientific claims that will enable the Commercial team to achieve set business objectives.
- Manages the development of new claims for all the company-owned products ensuring compliance to FDA and/or ASC.
Pharmacovigilance
- Oversees the management of all products/customer complaints involving company's products.
- Aids in resolving products/customer complaints via company helpdesk (including
employees) and provides immediate and timely product resolutions and interventions.
- Maintains a credible and accurate database of all recorded complaints and product issues; said database serves as reference for validation and future use.
- Conducts Pharmacovigilance Training to educate all employees of the standard reporting of any customer complaints and product issues.
Stakeholder Management
- Coordinates with internal and external stakeholders including various manufacturing suppliers to ensure compliance with FDA and QA requirements.
- Leads in the coordination with various suppliers in conducting scheduled audits and assists in the execution of the actual inspection and creation of post-inspection reports and recommendations.
Cost Planning and Budget Management
- Formulates budgets and ensures optimal allocation and use of all medical and regulatory affairs budget.
People Management
- Manages the overall team performance and ensures a high level of efficiency and effectiveness of the team.
- Engages in collaborative discussions while providing coaching and mentoring interventions to all team members.
- Collaborates with HROD on the upskilling, development and competency building of team members
Job requirements:
- With at least 7-10 years work experience in Regulatory Affairs
- Preferably with experience working in Pharmaceutical industry or FMCG
- Must be a licensed pharmacist
- Must be a QPIRA (Qualified Persons in Industry Regulatory Affairs) certificate holder issued by the FDA and a licensed Pharmacist
- Knowledgeable in DOH/FDA regulations on drugs, cosmetics, food, and devices and can facilitate registration processes, licensing, and promo permits
- Familiar with GMDSP (Good Manufacturing, Distribution and Storage Practices) and the manufacturing processes for low-risk dosage forms, medicinal products, dietary supplements, and cosmetics
- Strong background in Pharmacovigilance and CAPA Management
- Experienced in understanding regulatory documents and technical files, and is familiar with Supply Agreements and Technical Quality Agreements
