Sr. Scientist, Regulatory Affairs - Chemistry, Manufacturing & Controls (CMC)

Organon • Jersey City, NJ

413d

About The Position

The Senior Scientist in Regulatory Affairs is responsible for implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for assigned products. This role involves preparing and reviewing regulatory CMC dossiers, ensuring compliance with global regulations, and supporting project teams as needed. The Senior Scientist will lead the development of submission components and documentation, assess regulatory risks, and communicate potential issues to management.

Requirements

• Bachelor's degree in a science, engineering, or related scientific field with at least four years of relevant work experience, or an advanced degree with at least two years of relevant work experience.
• Minimum of two years of relevant CMC experience, including biological/pharmaceutical research or manufacturing.
• Proficiency in English; additional language skills are a plus.
• Experience in evaluating technical documentation for regulatory assessments.
• Familiarity with regulatory guidelines for product post-approval change management.

Nice To Haves

• Direct experience in Regulatory CMC and/or authoring of regulatory documentation.
• Device and/or combination product regulatory experience.

Responsibilities

• Provide input to global product and project regulatory strategies by assessing CMC changes and identifying global regulatory requirements.
• Execute global regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation.
• Ensure product compliance through timely and accurate maintenance of CMC submissions.
• Liaise with Manufacturing & Supply colleagues and external partners to support compliant execution of change management.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones for assigned products across the product lifecycle.
• Identify and communicate potential regulatory issues to Regulatory CMC management.

Benefits

• Retirement savings plan
• Paid vacation and holiday time
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree