About this opportunity
Regeneron Pharmaceuticals, Inc (USA) lists this Associate Director, Regulatory Affairs Strategy - Genetics Medicine opportunity in village of tarrytown, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Regulatory Affairs Strategy team. This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies, and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. We are committed to building a workplace with an inclusive culture.
When & where
Work Location: Tarrytown, NY or Warren, NJ. 4 days per week on site, 25% Travel may be required.
Roles and responsibilities
Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidances and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron’s development and marketing objectives within specified timelines
Liaison responsible for communication with FDA and other health authorities for assigned programs
Management of all regulatory activities associated with Regeneron drug development programs
Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals
Provide guidance to multidisciplinary teams on the regulatory requirements to support clinical development, include preparation and maintenance of IND or CTA filings
Oversee development of all regulatory filings in support of program
In collaboration with team, perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions
Perform reviews of clinical protocols and of clinical and preclinical study reports with respect to clarity, completeness, and regulatory requirements
Lead multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages
Accountable for ensuring the completeness and accuracy of information provided in regulatory submissions
Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation
Management of the planning, preparation and submission of licensing applications
Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) and MAA
Assist with the scientific writing and review of application
Evaluate conformance with the regulatory requirements, clarity, and completeness
Manage timelines/budgets with project management as appropriate and provide progress updates to senior management
Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
Provide training on applicable requirements for scientific staff as required
Qualifications
An MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred
A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experience
Research laboratory, process development or manufacturing experience with biotechnology products highly desirable
Must possess excellent written and verbal communication skills
Salary Range (annually) $176,100.00 - $287,300.00
Benefits
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:
annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits
For additional information about Regeneron benefits in the U.S., please visit
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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.