Position OverviewA Senior Manager, Regulatory Affairs Brands CMC is required by CareerWise Recruitment for our North Dublin based client. The Senior Manager Global Branded CMC (Chemistry, Manufacturing and Controls) Strategy possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Company portfolio.Location: North Dublin Office – 3 days on site per week.ResponsibilitiesEnsure global regulatory compliance with external requirements and internal quality procedures across all markets.Apply sound regulatory judgment, strategic thinking, and business acumen to develop and implement global regulatory strategies.Prepare, review, and deliver high‑quality CMC submissions for new registrations, post‑approval changes, renewals, and responses to agency queries.Lead CMC activities for assigned projects, including submission planning, risk assessment, and regulatory timelines tracking.Represent CMC on cross‑functional project teams, ensuring alignment with scientific, technical, and regulatory criteria.Maintain up‑to‑date regulatory documentation and systems, manage commitments, and ensure submission compliance.Collaborate effectively with internal and external stakeholders, including Regulatory, Quality, R&D, and global/regional teams.Serve as a technical and scientific resource for complex regulatory issues and provide mentoring to colleagues.Support implementation of regulatory policies, procedures, and continuous improvement initiatives across CMC functions.Build and maintain professional relationships with regulatory authorities and industry bodies to enhance regulatory success.Contribute to CMC‑related projects, training, and development programs, while modelling the Company’s values and behaviours.Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed.RequirementsMandatory hands‑on CMC authoring experience (initial registrations or post‑approval variations).Sufficient knowledge and solid understanding of development and commercial activities and cGMPs required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or projects.Advanced technical, functional, and industry knowledge to shape strategic direction of assigned projects, reduce regulatory burden and improve regulatory flexibility commensurate with business needs.Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/policy/publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.Advanced skills in written and oral communications (mandatory).Computer literacy with Microsoft Office Suite and Documentum‑based applications.Project management skills.Ability to engage in the external regulatory and pharmaceutical environment.Some experience serving as a Subject Matter Expert in specific relevant disciplines or as a resource for specific pharmaceutical science projects in specific regulatory domains.
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