Regulatory Pharmacist

RESPONSIBILITIES AND DUTIES:

• Ensures the legality, safety and efficacy of the company’s 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 company’s 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

• Bachelor’s 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