Regulatory Counsel Senior Lead
4 days ago
Based in the IP & Access to Medications team at Jazz Pharmaceuticals, we are seeking a highly experienced Regulatory Counsel Senior Lead to serve as a subject matter expert on regulations and laws impacting research and global development within the biopharmaceutical industry.
The ideal candidate will have ten or more years of combined experience, preferably with work experience at FDA CBER/CDER and in-house experience in the biopharmaceutical industry. A thorough knowledge of the Food, Drug & Cosmetic Act, associated regulations, FDA Guidance, and regulatory practices of the U.S. Food and Drug Administration in the regulation of small molecules, biologics, and companion diagnostics is essential.
This role reports to Vice President, Senior Associate General Counsel, Intellectual Property & Access to Medications Team, Legal and resides within the Regulatory Law & Strategy Center of Excellence.
Key Responsibilities- Proactively identify and provide strategic regulatory legal guidance for highly complex/non-standard US/regional/global programs, particularly in the oncology and neurology therapeutic areas.
- Provide expert regulatory legal advice to cross-functional teams engaged in collaborative research and development activities, including Global Regulatory Affairs & Drug Safety (GRADS), R&D, and Global Product Commercialization Teams.
- Collaborate with colleagues in the Intellectual Property and Access to Medicines team, as well as colleagues throughout Legal, to develop comprehensive legal strategies to optimize the development programs of Jazz's differentiated products and pipeline.
- Collaborate with Legal, Corporate and Government Affairs (LCG) colleagues and cross-functional teams to ensure appropriate expertise is applied to specialized issues, including regulatory strategy, product development & product approvals; promotion; post-approval compliance; FDA enforcement actions & litigation; due diligence reviews & transactional support.
- Keep abreast of changes in laws and regulations that may impact the regulation of Jazz product offerings and identify opportunities to influence and share learnings with internal stakeholders and colleagues.
We offer a competitive salary range of $236,000 - $354,000 per year, depending on qualifications and experience. In addition to your base pay, you may also be eligible for a discretionary annual cash bonus or incentive compensation, as well as discretionary equity grants.
Required Skills and Qualifications- Juris Doctor degree from an accredited law school; admitted to a US state bar in good standing.
- Scientific or technical degree not required, but desirable.
- Ten or more years combined experience. Work experience at FDA CBER/CDER is highly preferred; in house experience in the biopharmaceutical industry a plus. Preferably, the candidate should have experience counseling biopharma companies in all stages of development with experience in the oncology area.
- Current and thorough knowledge of the Food, Drug & Cosmetic Act, associated regulations, FDA Guidance, and regulatory practices of the U.S. Food and Drug Administration in the regulation of small molecules, biologics, and companion diagnostics.
- Experience with setting global strategies and working knowledge of global (ex-US) health authorities, such as EMA, Health Canada, PMDA, and their associated regional/country regulations highly desirable.
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