Merck
Job Description
This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
Primary responsibilities include, but are not limited to:
Regulatory Responsibilities:
Technical Skills:
Leadership Skills:
Qualifications & Skills
Bachelor’s in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
Minimum 5 – 7 yrs of Industry Pharmaceutical industry experience out of 4 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics The candidate may be required to travel to other CMO sites on a need basis.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Required Skills:
Adaptability, Adaptability, Business Decisions, Change Controls, Collaborative Leadership, Compliance Investigations, Documentation Review, Documentation Standards, Electronic Common Technical Document (eCTD), Employee Training Programs, Global Coordination, Global Regulatory Submissions, Legal Compliance, Life Cycle Planning, Pharmaceutical Manufacturing, Pharmaceutics, Policy Implementation, Records Retention Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Management, Regulatory Processes {+ 7 more}
Preferred Skills:
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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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
50%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
NA
Job Posting End Date:
10/6/2026
*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.