Senior Manager, Regulatory Affairs - CMC

Job Description

Senior Manager, Regulatory Affairs - CMC

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 (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 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

• 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 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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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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