Director, Regulatory Affairs Companion Diagnostics

Location
Tarrytown, NY, United States
Posted
Jan 28, 2021
Ref
23363BR
Required Education
Masters Degree/MBA
Position Type
Full time
Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. As part of this initiative, the Companion Diagnostics (CDx) Team in Regulatory Affairs is integrated with the Global Regulatory Strategy (GRS) Group. This will allow us to promote early adoption of biomarker strategy to guide clinical translation. The RA CDx Team along with the RA GRS Group collaborate with the Precision Medicine and Clinical Sciences Teams to help develop the biomarker strategy and execution to achieve proof of mechanism/concept in early clinical trials. The team also implements Precision Medicine strategies to support late-stage clinical programs and companion diagnostics.

The Associate Director/Director, RA CDx will work closely with their RA GRS counterparts, the companion diagnostics team and key cross-functional partners to deliver Companion Diagnostics (CDx) at Regeneron. We want the successful candidate to have CDx experience and be a strong leader with excellent communication and collaborative skills and work well in a team-based environment
In this role, a typical day might include the following:

Support the implementation and execution of Regeneron RA CDx strategy in collaboration with key partners and ensure that development timelines, regulatory pathways and commercialization plans are coordinated.

Lead both programs and staff to ensure that all programs considering and/or requiring CDx support have the required RA CDx support.

Lead/manage relevant meetings, proactively identify issues and/or risks and develop mitigation plans, set priorities, direct projects and people, work cross-functionally to manage expectations and project needs.

Build and maintain positive partner relationships (internal and external).

Communicate to teams and Senior Management internal updates including identification of potential risks for CDx programs.

Be knowledgeable of and current with industry trends, new technologies and global regulations pertaining to CDx.
This role might be for you if:
  • We seek an advanced degree required (Masters and above).
  • We ask for a Minimum 8 years pharmaceutical or diagnostics industry experience including a minimum of 3 years RA CDx experience.
  • Excellent written and verbal communication skills are crucial.
  • Must possess strong leadership skills and prior management experience.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.