7 Senior Manager, Regulatory Affairs Jobs in Tarrytown, NY
Regeneron is Hiring a Senior Manager, Regulatory Affairs Near Tarrytown, NY
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 clinical development.
In this role, a typical day might include the following:
- 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.
- Represent RA IVD on clinical study teams, global regulatory study teams for assigned projects to ensure chances for regulatory submissions success are maximized.
- Coordinate and manage reviews and revisions of regulatory submissions such as SRDs, IDEs, Performance Study Applications, 510(k)s and PMAs.
- Oversee Health Authorities inquiries by distributing questions and coordinating with internal personnel for timely responses.
- Stay abreast of changing regulations globally throughout the IVD lifecycle and develops solutions with members of RA IVD team to provide updates to the organization.
- Build and maintain cooperative relationships as the point of contact with IVD providers and project teams.
- Provide support to RA IVD department processes e.g. submission management and participates in internal RA IVD department initiative.
- Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA)
- Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs
- Customer focused with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.
Minimum 8-10 years’ 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
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. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)$145,400.00 - $237,200.00
Job Summary
Full Time
Business Services
$146k-194k (estimate)
06/20/2024
07/14/2024
regeneron.com
TARRYTOWN, NY
7,500 - 15,000
1988
$5B - $10B
Business Services
Related Companies
About Regeneron
Get in the Ideas Business. At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work together to discover, invent, and develop biopharmaceutical medicines, were creating whole new ways of thinking about science, manufacturing and commercialization. And whole new ways of thinking about health. So connect with us. Tell us about you. Learn more about our life-changing medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for more information on how to engage with Regeneron on social media.... An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media. We do not interview candidates on Google Hangouts. Any questions about job listings can be directed to candidatesupport@regeneron.com.
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The job skills required for Senior Manager, Regulatory Affairs include Regulatory Affairs, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Manager, Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Manager, Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
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