Manager, Regulatory Affairs - CMC
Manager, Regulatory Affairs - CMC
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Job Description
Job Description
Manager Regulatory Affairs CMC
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 leadingedge 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 were 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:
- 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 postapproval 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 document 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 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 proud to be a company that embraces the value of bringing diverse talented and committed people fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively for the common good. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current 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 preexisting 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):
Job Posting End Date:
05/16/2025*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
