International award-winning executive recruitment expert Monroe Consulting Group is recruiting on behalf of a fast-growing multinational pharmaceutical company in Vietnam, we are seeking a Head of Regulatory Affairs Manager with at least 8 years of Regulatory affairs experience in the pharmaceutical and consumer health industry.
This position will be responsible for managing all regulatory activities to ensure compliance of the company's Pharmaceutical and Consumer Health product portfolios (produced in Vietnam, imported to Vietnam, and exported from Vietnam) to the related regulation (Vietnam, ASEAN, new markets out of ASEAN), driving the company's objectives and planning to support business goals.
- Develop, support, and implement registration strategy and plan for all company products
- Responsible for the applications and approvals for new, renewed products and variations within the set time frame and accuracy.
- Provide regulatory expertise to support company business
- Conduct in compliance with local regulatory agency requirements as well as relevant company policy and internal SOPs
- Closely liaise with the factory (R&D, QA, and QC) to ensure locally manufactured product documents are fully compliant and ready with Vietnam regulations.
- Provide support and if need to be lead GMP inspection of factory
- Manage Pharmacovigilance
- Liaise with Global team for all initiatives and support for Regulatory Affairs task in Sea region
- Lead, manage, and coach the Local Regulatory Affairs Team through the development of skills and capabilities of team members. Motivate members to build a good working environment and gain commitment from teams
- Pharmacist or equivalent education in life science (biology, chemistry, etc.)
- At least 8 years of experience in regulatory affair function with at least 2 years in a management role at multinational pharmaceutical companies
- Strong knowledge of the Vietnamese regulatory environment and excellent understanding of all stages of drug registration
- Direct interaction/negotiation with regulatory authorities
- Motivated, self-starter, and ability to work independently