Senior Manager, Regulatory Affairs - CMC
Senior Manager, Regulatory Affairs - CMC
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Job Description
Job Description
This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations guidances 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.
Primary responsibilities include but are not limited to:
Regulatory Responsibilities:
- Provide input to global product and project regulatory strategies by performing assessments of CMC changes identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execute regulatory strategies by leading the development authoring and review of CMC submission components and documentation to support post-approval supplements/variations annual reports registration renewals and responses to health authority questions per established business processes and systems.
- Liaise with global CMC Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- 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 GRACS CMC management as needed
- Technical Skills:
- Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g. pharmaceutical manufacturing analytical testing and quality assurance).
- Proficient computer skills and previously demonstrated ability to operate in electronic documentam based GMP systems
Leadership Skills:
- Demonstrated ability to generateinnovative solutions to problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Demonstrated effective leadership communication and interpersonal skills
Qualifications & Skills
- Bachelors 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 10 12 yrs of Industry Pharmaceutical industry experience out of 6 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.
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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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Animal Vaccination Applied Engineering Biochemistry Biopharmaceutical Industry Business Business Management Business Processes Chemical Engineering Communication Management Detail-Oriented Document Coordination Electronic Common Technical Document (eCTD) Employee Training Programs GMP Compliance Immunoassays Immunochemistry Interpersonal Relationships Management Process Mentorship Microbiological Analysis Microbiology Molecular Biology Molecular Microbiology 19 morePreferred Skills:
Job Posting End Date:
07/10/2025*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:
Senior Manager
Employment Type
Full-Time
