Senior Manager, Regulatory Affairs - CMC
- Merck Sharp
- 10 - 12 years
- Mumbai
- 22 days ago
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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.
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 (eg, 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 generate innovative 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.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & Regulatory
Role Category: Corporate Affairs
Role: Regulatory Affairs Compliance
Employement Type: Full time
Contact Details:
Company: Merck SharpLocation(s): Mumbai
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Keyskills: CVS Change management Manager Quality Assurance Microbiology Analytical Pharmacy Healthcare Biochemistry GMP Molecular biology
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