Senior Specialist, CMC Regulatory Affairs - Quality Compliance

Regeneron Pharmaceuticals

4d•$78,700 - $128,700•Onsite

About The Position

Regeneron is seeking a Senior Specialist to join its CMC Regulatory Affairs team and support manufacturing and quality teams in an onsite work model at its Rensselaer site. The role assesses regulatory impact from quality events and quality system actions, and drives compliance activities to resolution in collaboration with Quality, Manufacturing, Supply, and CMC Regulatory Affairs stakeholders. The position contributes to a science-driven organization developing medicines for people with serious diseases.

Requirements

Bachelor’s degree in chemistry, biology, or a related field.
At least 2 years of relevant biotechnology or pharmaceutical industry experience.
Strong CMC and quality compliance experience, including driving quality system actions and events to closure.
Proven experience assessing the 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 working 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.

Nice To Haves

Advanced qualification or CMC experience may be considered.

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 to 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.
Build positive relationships while supporting continuous process improvement.

Benefits

Annual bonuses or other incentive plans may be offered, depending on country and role.
Equity awards may be offered, depending on country and role.
Pension or retirement benefits may be offered, depending on country and role.
401(k) company match may be offered, depending on country and role.
Health and wellness programs may be offered, depending on country and role.
Fitness centers may be available, depending on country and role.
Insurance benefits may include medical, dental, vision, life, and disability insurance, depending on country and role.
Paid time off may be offered, depending on country and role.
Family support benefits may be offered, depending on country and role.
Reasonable accommodation is available to applicants with known disabilities or chronic illnesses during recruitment, unless it would impose undue hardship.