Senior Specialist, CMC Regulatory Affairs - Quality Compliance

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 Senior Specialist, CMC Regulatory Affairs - Quality Compliance, to join our CMC Regulatory Affairs team, supporting our manufacturing and quality teams in a onsite work model. In this role, you will assess regulatory impact from quality events and quality system actions while driving compliance activities to resolution while collaborating with Quality, Manufacturing, Supply, and CMC Regulatory Affairs stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

 

When & where:

Site: Rensselaer

Work Model: Onsite

 

Discover your role:

• Assess product license impact from quality system changes and deviations.
• Evaluate regulatory impact of manufacturing processes and procedures as a subject matter expert.
• Own change controls, document workflows, and corrective and preventive actions through closure.
• Draft procedures, reports, and presentation materials with a high standard of quality.
• Lead quality compliance onboarding activities for the CMC Regulatory Affairs team.
• Collect, analyze, and present quality compliance metrics to CMC Regulatory Affairs.
• Monitor compliance support requests, triaging and escalating issues appropriately.
  • You build positive relationships while supporting continuous process improvement.

 

This role requires:

• Bachelor’s degree in chemistry, biology, or a related field.
• 2+ years of relevant biotechnology or pharmaceutical industry experience.
• Advanced qualification or CMC experience may be considered.
  • Strong CMC and quality compliance experience, including driving quality system actions and events to closure.
• Proven experience assessing regulatory impact of change control
• Strong understanding of quality principles within a regulated manufacturing environment.
• Ability to develop proficiency in electronic quality, regulatory, and document management systems.
• Experience running work within digital workflows and data repositories such as QMS systems and Veeva Vault.
• Strong relationship-building skills with internal and external stakeholders.
• Clear, precise communication skills across organizational levels.
• Strong attention to detail and adaptability to change.
• Dedication to continuous process improvement.
  

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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, and 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)

$78,700.00 - $128,700.00