The Regulatory Pharmacist plays a key role in ensuring that all pharmaceutical products created or handled by the company meet legal regulations and standards, enabling their smooth production, distribution, and sale under the brands and businesses of the company. They are expected to be regularly updated on policies and processes set by the FDA (Food and Drug Administration) and other relevant government organizations regarding pharmaceuticals and cosmetics. They also regularly conduct product research and testing, making recommendations that can be included in the companies portfolios for clients and end-users.
Responsibilities And Duties
- Ensures the legality, safety and efficacy of the companys pharmaceutical products
- Coordinate with warehouse and logistics teams of proper product storage, handling and transport.
- Manage and facilitate the end-to-end process of FDA registrations, ensuring compliance of the companys products with all relevant regulations and standards.
- Functions as the technical point person on regulatory concerns, ensuring to be updated of the latest trends, changes in product registrations, licensing, and other related processes
- Provide updates/reports on regulatory input in order to obtain timely regulatory approvals of the products as part of the product development planning
- Conduct product research and product surveys for marketability in coordination with Marketing, evaluating and recommending potential additions to the companies portfolio of products
- Create product business plan: product studies, market research, marketing plan
- Maintain complete and proper documentation of product registrations and other relevant items, keeping track of timelines for licenses that are under process or those near expiry, for renewal
Job Qualifications
- Bachelors Degree in Pharmacy or equivalent
- Must be a licensed Registered Pharmacist (RPh)
- At least 6 months to 1 year of relevant work experience in Research & Development; fresh graduates may be considered
- Detail-oriented and willing to learn
- Excellent oral and written communication skills
- Good organizational and multitasking skills
- Good interpersonal skills, able to communicate effectively across different levels
- Knowledgeable in MS Word, Excel, Outlook, and other Office software
- A team player with the ability to work with minimal supervision
