Manager, Regulatory Affairs CMC
Manager, Regulatory Affairs CMC
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Job Description
Job Description
Responsible for implementing CMC regulatory strategies for assigned products in
accordance with global regulations and guidances; and is responsible for the
preparation and submission of CMC dossiers for pipeline and commercial products.
Accountable for the delivery of regulatory milestones for less complex projects
through the product lifecycle.
Participate in the development communication lifecycle management and
review of the CMC Regulatory Strategy Document for smaller-scoped projects.
Execution of CMC documentation including IND/CTA NDA/BLA/MAA post approval
supplements annual reports registration renewals and responses to
health authority questions per established business processes and systems.
Experience in reviewing scientific information and assessing whether technical
arguments are clearly presented and conclusions are adequately supported by
data.
Applying oral and written communication skills and the ability to communicate
issues in a succinct and logical manner. Strong listening skills.
Applying understanding of related fields (e.g. manufacturing analytical quality
assurance).
Flexibility in responding to changing priorities or dealing with unexpected events
Current Employees apply HERE
Current Contingent Workers apply HERE
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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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
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 CommunicationsPreferred Skills:
Job Posting End Date:
09/30/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Employment Type
Full-Time
