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Corporate Counsel, US Regulatory Law
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- This position reports into the US Regulatory and Safety legal team, focusing primarily on US regulatory law matters with responsibility for interpreting and advising on the implementation of key FDrelated laws, regulations and policies, counseling the business regarding regulatory exclusivities, product lifecycle planning, pediatric studies, post-marketing regulatory commitments, generic and biosimilar market entry, and regulatory requirements associated with product labeling.
- Counseling clients on the Federal Food, Drug, and Cosmetic Act and FDA regulations and guidance documents, the Hatch-Waxman Act and associated regulatory exclusivities, product lifecycle planning, pediatric studies, post-marketing regulatory commitments, drug review and approvals, labeling and citizen petitions.
- Providing specialized legal support to Medical, Commercial and Regulatory teams on FDA regulations and enforcement on advertising and promotion.
- Counseling Pharmacovigilance Operations in matters of regulatory compliance and enforcement.
- Liaising with Compliance and Legal Division colleagues as needed, including global product counsel, litigation, IP, and transactional partners.
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