Sr. Manager GPS Agreements & Licensing

This position resides in the Global Patient Safety (GPS) organization of Regeneron in the Agreements & Licensing area, and would be responsible for authoring and leading the end to end maintenance and finalization of Safety Agreements (also known as Safety Data Exchange Agreements (SDEAs) or Pharmacovigilance Agreements (PVA)) with Alliance Partners (APs) and other external collaborative parties to ensure clarity, consistency and compliance with safety reporting requirements globally. This role is also responsible for supporting divestments and acquisitions to/from Alliance Partners on behalf of Global Patient Safety.

A typical day in this role might look like....

• Prepare (author, review, resolve comments and negotiate) and finalize SDEAs to meet study and other development/commercialization timelines
• Act as the primary point of contact on the SDEA for internal (e.g., Legal, Business Development, Regulatory Affairs, Strategic Alliance, etc.) and external collaborators (e.g., Alliance Partners, Collaborative Partners, etc.)
• Coordinate internal and external collaborator approval of the SDEA by soliciting comments and resolving all issues, as the need arises.
• Ensure SDEA terms are aligned with Regeneron’s internal standards, and whenever feasible, aligned across APs and/or projects during personal review and/or leadership of team/direct reports
• Lead meetings internally, externally and/or jointly with internal and external collaborators
• Coordinate implementation steps within GPS for SDEA related tasks
• Project management of divestments and acquisitions with Alliance Partners that impact Global Patient Safety and Pharmacovigilance
• Handle results and maintain compliance with SOPs, AP agreement and applicable worldwide regulations to ensure timely and consistent results
• Provide input for GPS process improvement activities, whether internal or involving groups external to GPS or Regeneron, including vendors or Alliance Partners
• Assist with partner audits and inspections as they relate to SDEAs

This role might be for your if.....

• A minimum of a Bachelor's degree
• A minimum of 10 years of experience in pharmacovigilance
• At least 2 years of experience preparing SDEA's and collaborating with Alliance Partner

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$126,600.00 - $206,600.00