The Regulatory and Safety Legal team advises a wide variety of client groups on all aspects of medicines and medical devices regulation, globally. The team also provides strategic legal and regulatory counseling on Board of Health regulatory requirements for Pfizer’s Safety Operations. Key clients and collaborators include Regulatory Sciences, Safety, Medical, Corporate Affairs, Pfizer business units, Business Development, and other legal practice groups.
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 FDA-related 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. The role also involves partnering with Regulatory Sciences and Corporate Affairs colleagues to advance initiatives important to Pfizer.
We are seeking an attorney who is interested in working in a challenging, dynamic environment supporting a variety of client groups. Specific responsibilities in the US regulatory law area include:
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 regarding applicable federal and state laws and regulations, including drug sampling, and drug importation.
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.
Bachelors degree or equivalent.
Juris Doctorate or equivalent.
Member of a state bar/admitted to a relevant jurisdiction.
7+ years of experience working in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry.
Prior experience including matters involving counseling on the interpretation of FDA-related legislation and regulations.
Proven ability to proactively identify and analyze potential legal issues and develop creative and business focused legal advice and solutions.
Proven ability to cultivate strong client relationships and successfully influence leadership in a fast paced, innovative business environment.
Excellent written and verbal communication skills.
Flexibility to travel as needed.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Nice to Have:
Self-motivated and able to handle multiple demands and priorities simultaneously.