Senior Specialist, CMC Regulatory Affairs - Quality Compliance

About the role

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 an 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.

Work model & location

Site: Rensselaer. Work model: Onsite.

Responsibilities

• 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.

Requirements

• 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.

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., visit careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Pay

Salary range (annually): $78,700.00 – $128,700.00 (Canada). 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.