MSD Pharmaceuticals - Senior Manager - CMC Regulatory Affairs

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Right now, thousands of MSD associates are working to cure the world's most complex diseases. We know that our people are the key to our success, which is why our Human Resources division takes pride in building teams of skilled, forward-thinking individuals who contribute to MSD's pioneering medical advancements. We share a spirit of attentive enthusiasm that helps support our associates in achieving new milestones in global healthcare.

Role Summary

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies. The Senior Manager - Regulatory Affairs CMC is responsible for the preparation and review of the information required for the development of regulatory CMC dossiers for commercial products.

Key Responsibilities:

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, MMD 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 an electronic document 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 MSD/ CMO sites on a need basis.

What we offer at MSD?

Your role at MSD 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. At MSD, we- reinventing for life.