Senior Manager Regulatory Affairs Brands CMC

A 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 & 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

Role of this position

• Ensure 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 modeling the Company’s values and behaviors.
• Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed.

JOB REQUIREMENTS

• Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)
• Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).
• Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s), 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 & 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 domain(s).

Please call Tom Devaney for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.