Manager Combination Products - Regulatory Affairs

Regeneron Pharmaceuticals, Inc.; Warren (MI); Presencial; USD 108.000 - 176.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, v

Paid time off

Family support benefits

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team in an onsite capacity.

You will support global combination product development, regulatory submissions, and post-market activities while collaborating with Regulatory Affairs, Manufacturing, Quality, and stakeholders. The role emphasizes US and global regulatory requirements for combination products, with experience in INDs/BLAs, human factors, and post-approval

Formación

• Bachelor's degree with 6+ years related experience, or advanced degree with 3+ years related experience in pharmaceutical or biotechnology settings.
• 2-4 years of CMC Regulatory Affairs experience supporting worldwide regulations.
• Strong understanding of global CMC Regulatory Affairs requirements, including combination products and human factors.
• Experience delivering marketing authorizations, CTA/INDs, and post-approval submissions.
• Experience supporting biologics and combination products preferred.
• Experience engaging with FDA or other regulatory authorities preferred.
• Ability to assess regulatory impact, support compliance activities, and mentor junior staff.
• Strong communication, negotiation, strategic thinking, problem-solving, prioritization, and cross-functional collaboration skills.

Responsabilidades

• Support combination product development from early phase through post-market activities.
• Review regulatory filings including INDs, BLAs, MAAs, annual reports, and supplements.
• Develop design control documentation and quality systems for combination products.
• Assess changes and deviations for regulatory impact and submission requirements.
• Support regulatory authority meetings, responses, and inspections.
• Create SOPs, Working Instructions, and Reviewer's Guides.
• Identify process gaps and support regulatory intelligence activities.
• Translate ambiguity into action and build effective stakeholder partnerships.

Conocimientos

Communication skills

Negotiation

Strategic thinking

Problem solving

Cross-functional collaboration

Educación

Bachelor's degree with 6+ years related experience

Advanced degree with 3+ years related experience

Descripción del empleo

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Regulatory Affairs - Combination Products to join our Regulatory Affairs team, supporting our combination product business area in an onsite work model. In this role, you will support global combination product development, regulatory submissions, and post-market activities while collaborating with Regulatory Affairs, Manufacturing, Quality, and combination product stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide .

When & where:

Rensselaer, New York

Work model:

Onsite, 5 days per week

Discover your role:

• Support combination product development from early phase through post-market activities.
• Review regulatory filings including INDs, BLAs, MAAs, annual reports, and supplements.
• Develop design control documentation and quality systems for combination products.
• Assess changes and deviations for regulatory impact and submission requirements.
• Support regulatory authority meetings, responses, and inspections.
• Create SOPs, Working Instructions, and Reviewer's Guides.
• Identify process gaps and support regulatory intelligence activities.
• You translate ambiguity into action and build effective stakeholder partnerships.

This role requires:

• Bachelor's degree with 6+ years related experience, or advanced degree with 3+ years related experience in pharmaceutical or biotechnology, settings.
• 2-4 years of CMC Regulatory Affairs experience supporting worldwide regulations.
• Strong understanding of global CMC Regulatory Affairs requirements, including combination products and human factors.
• Experience delivering marketing authorizations, CTA/INDs, and post-approval submissions.
• Experience supporting biologics and combination products preferred.
• Experience engaging with FDA or other regulatory authorities preferred.
• Ability to assess regulatory impact, support compliance activities, and mentor junior staff.
• Strong communication, negotiation, strategic thinking, problem-solving, prioritization, and cross-functional collaboration skills.
• Ability to support training activities and proactively address technical or regulatory knowledge gaps.

We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$108,000.00 - $176,000.00