Regulatory Research Manager - United States
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- Responsible for gathering, managing, interpreting, and communicating regulatory intelligence information relevant to company products and regulatory activities. Prepares and coordinates communications with FDA as assigned. Serves as US Agent for Rx submissions from company’s foreign entities.
- Analyze the known and potential impact of new FDA policies, guidance, rules, and regulations on company's new product pipeline and commercial portfolio. Compile, summarize, and communicate Regulatory Intelligence information to company leadership and Scientific Affairs staff. Monitor HHS, ICH and other regulatory agency websites for new regulatory information including, but not limited to: new guidance documents, relevant product approvals, patent listings, drug shortages, new rules and regulations, and public meetings.
- Provide expert advice to Rx new product development teams. Work directly with FDA, trade associations and outside regulatory and legal experts to influence emerging legislation, regulations, guidance and FDA decision making on matters material to our company.
- Prepare and submit company's Comments to the Docket for relevant new FDA policies, guidance, rules, and regulations.
- Prepare, submit, and follow up on Controlled Correspondence, Drug Shortage and other FDA related communications.
- Support and lead a continuous improvement environment. Direct and manage contacts with outside consultants to resolve complex regulatory issues.
- Projects as assigned by Sr. Dir. Rx Regulatory Affairs.
- Advanced knowledge of FDA regulations and policies applicable to human drug products.
- Familiarity with web-based resources applicable to drug regulation (e.g., Code of Federal Regulations, FDA guidance, US Pharmacopoeia, Federal Register, Regulations.gov, etc).
- Must demonstrate advanced analytical skills, the ability to identify and apply policies and general regulations to specific products or projects in our company's portfolio.
- Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for executive stakeholders inside and outside of our company Regulatory Affairs.
- Advanced verbal and written presentation and communication skills are necessary.
- The ability to effectively seek out regulatory information relevant to our company’s product portfolio is required.
- Advanced knowledge of scientific, regulatory, and legal terminology is necessary.
- These skills are normally acquired through possession of a bachelor degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined with 8-10 years of experience in the health care or pharmaceutical industry and 10+ years of hands on experience in regulatory affairs.
- Advanced degree preferred.