Manager, Regulatory Affairs CMC

Responsible for implementing CMC regulatory strategies for assigned products inaccordance with global regulations and guidances; and is responsible for thepreparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projectsthrough the product lifecycle. Participate in the development, communication, lifecycle management andreview of the CMC Regulatory Strategy Document for smaller-scoped projects. Execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post approvalsupplements, annual reports, registration renewals and responses tohealth authority questions per established business processes and systems. Experience in reviewing scientific information and assessing whether technicalarguments are clearly presented, and conclusions are adequately supported bydata. Applying oral and written communication skills and the ability to communicateissues in a succinct and logical manner. Strong listening skills. Applying understanding of related fields (e.g., manufacturing, analytical, qualityassurance). Flexibility in responding to changing priorities or dealing with unexpected eventsCurrent Employees apply HERECurrent Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License

Hazardous Material(s)

Required Skills

Adaptability, Communication, Compliance Investigations, Documentation Standards, Electronic Common Technical Document (eCTD), Employee Training Programs, Global Regulatory Submissions, Management Process, Pharmaceutical Manufacturing, Policy Implementation, Records Retention Management, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Communications

Preferred Skills

Job Posting End Date

09/30/2025

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Requisition ID

R364297