Manager, Regulatory Affairs - United States
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- Collaborate with the project team to develop regulatory strategy, milestones and submission deliverables for the development of new adult and toddler nutritional products.
- Execute regulatory activities per the project plan to assure new products meet submission, approval and commercial launch goals.
- Support manufacturing and procurement in the management of change to existing commercial products.
- Maintain product labeling in compliance with laws and regulations.
- Negotiate directly with FDA and other health authorities to resolve regulatory issues.
- Coach and develop junior staff members to become proficient in regulatory decision making.
- Must possess excellent analytical skills and the ability to apply policies and general regulations to specific products or projects.
- Good verbal and written communication skills are necessary. Demonstrated leadership skills are required.
- The ability to work effectively on project teams is required. Knowledge of scientific, regulatory and trade dress terminology is necessary.
- These skills are normally acquired through possession of a bachelor degree in a health sciences field such as biochemistry, chemistry, pharmacy or pharmacology, combined with a minimum of 3 years of experience in the nutrition or regulatory. Bachelor degree in a health care related science (e.g. biochemistry, chemistry, pharmacy, pharmacology) required. Masters or Ph.D. preferred.