Lead CMC Regulatory Scientist – Global Submissions (Hybrid)

Merck & Co.; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co. in Rahway, NJ is seeking a Regulatory CMC Principal Scientist to develop and implement global CMC regulatory strategies for pharmaceutical products, leading dossiers and submissions to support market approvals.

The role requires strong regulatory leadership, cross-functional collaboration, and a track record of guiding IND/CTA and NDA/MAA packages, with a focus on compliant, timely launches.

Qualifications

• B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry.
• 5-10 years of pharmaceutical development experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
• At least 7 years' experience in Regulatory CMC roles, leading the preparation of NDA/MAA CTD content.
• The candidate must be proficient in English; additional language skills are a plus.

Responsibilities

• Serve as a CMC Product Lead for new small molecule and peptide pharmaceutical products and be accountable for the delivery of all regulatory milestones throughout product development including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of new product submissions.
• Provide regulatory leadership, oversight, and strategy to a matrixed team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule and peptide development products.
• Provide regulatory leadership as needed in product in-license/due diligence review
• Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Identify, communicate and elevate potential regulatory issues to GRACS CMC management, as needed.
• Continuously evaluate and develop talent within the team and prepare a succession plan.
• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our company pharmaceutical products worldwide.
• Conduct all activities with an unwavering focus on compliance.

Skills

Regulatory CMC

Leadership

Regulatory strategy

Communication

Problem solving

Education

B.S. in biological science or related field

Advanced degree preferred

Job description

Merck & Co. in Rahway, NJ is seeking a Regulatory CMC Principal Scientist to develop and implement global CMC regulatory strategies for pharmaceutical products, leading dossiers and submissions to support market approvals.

The role requires strong regulatory leadership, cross-functional collaboration, and a track record of guiding IND/CTA and NDA/MAA packages, with a focus on compliant, timely launches.