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Senior Manager, Regulatory Affairs IVD & CDx

unlimited holidays - extra holidays - extra parental leave

Remote:

Full Remote

Contract:

Full time

Salary:

145 - 237K yearly

Experience:

Expert & Leadership (>10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor's degree in Life Sciences or related field, 8-10 years' experience in pharmaceuticals or diagnostics, 3+ years in IVD/Medical Device Regulatory Affairs, Experience with US Medical Device submissions, Familiarity with international IVD regulations.

Key responsabilities:

Develop and execute IVD strategy with stakeholders
Represent RA IVD on clinical study teams
Manage regulatory submission reviews and revisions
Coordinate responses to health authorities inquiries
Maintain relationships with IVD providers and project teams

Regeneron Biotech: Biology + Technology Large https://www.regeneron.com/

5001 - 10000 Employees

See more Regeneron offers

Job description

Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with the Precision Medicine and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical portfolio.

In this role, a typical day might include:

The Senior 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. The successful candidate will have IVD Medical Device experience and have excellent communication and collaborative skills that is able to work well in a team-based environment.

This role might be for you if can:

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.
Customer focused with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations.

To be considered for this opportunity, you must have the following:

Bachelors degree in Life Sciences, Engineering or related technical field
Minimum 8-10 years’ pharmaceutical or diagnostics industry experience including 3+ years IVD/Medical Device Regulatory Affairs experience.
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
Excellent written and verbal communication skills
Experience with companion diagnostic development processes and regulatory filings

#GDRAJobs

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