Senior Manager, Regulatory Affairs
23 hours ago
Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA) Team collaborates with the Regulatory Affairs Global Regulatory Strategy Group (GRS), Precision Medicine, and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical portfolio.
The Sr. Manager, Regulatory Affairs IVD will work closely with their RA GRS counterparts, the Companion Diagnostics (CDx) team, and key cross-functional stakeholders to deliver novel in vitro diagnostics in support of clinical development.
In this role, a typical day might include the following:
1. Contribute to the development and execution of IVD strategy in collaboration with key stakeholders and ensure that development timelines, regulatory pathways, and commercialization plans are coordinated.
2. Represent RA IVD on clinical study teams and global regulatory study teams for assigned projects to maximize chances for regulatory submission success.
3. Coordinate and manage reviews and revisions of regulatory submissions such as SRDs, IDEs, Performance Study Applications, 510(k)s, and PMAs.
4. Oversee Health Authorities inquiries by distributing questions and coordinating with internal personnel for timely responses.
5. Stay abreast of changing regulations globally throughout the IVD lifecycle and develop solutions with members of the RA IVD team to provide updates to the organization.
6. Build and maintain cooperative relationships as the point of contact with IVD providers and project teams.
7. Provide support to RA IVD department processes e.g., submission management and participate in internal RA IVD department initiatives.
This Role May Be For You If You Have:
1. Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA).
2. Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs.
3. Customer focused with the ability to balance and manage multiple projects from multiple stakeholders to meet time and quality expectations.
To be considered for this opportunity, we are looking for:
Bachelor's degree in Life Sciences, Engineering, or related technical field.
Minimum 8-10 years of pharmaceutical or diagnostics experience including 3+ years IVD/Medical Device Regulatory Affairs experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
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