Director - Regulatory Affairs Brands CMC, Dublin Pike

Director - Regulatory Affairs Brands CMC is required by CareerWise Recruitment for our North Dublin based client. The Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls), is an emerging Senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The position is primarily devoted to the independent development of strategic CMC regulatory approaches to expedite the preparation and review of regulatory submissions in support of the Company product portfolio.

Location: North Dublin Office– 3 days on site per week

THE ROLE:

Cultivates sustainable&effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.

Interprets CMC regulatory requirements, develops strategies (including novel approaches), assesses risks and develops contingency proposals.

Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control.

Ensures all CMC regulatory activities are executed effectively&efficiently, and in compliance with external regulatory requirements&internal quality procedures.

Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries.

Presents and articulates issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.

Manages, leads and contributes significantly to Company projects and initiatives within cross-functional project teams.

Executes training related activities (e.g. compliance-related, HR policies)&individual development plans, participates in cross-disciplinary forums and learning opportunities, engages in Straight Talk&Listen exchanges, demonstrates and models adherence to all the Company's behaviors&values, embraces&complies with Principles of Integrity.

Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.

Serves on governance&steering committees and may serve as the global CMC lead in Due Diligence exercises

Serving as a People Manager:

Provides guidance&direction to direct reports, managing resources, resource capacity&budget along with prioritizing workload appropriately.

Accomplishes performance-management&training related activities, encourages&supports a healthy work/life balance, supports roll-out of HR policies, takes hiring-related decisions, participates in succession planning, provides guidance&facilitates opportunities for talent development, encourages colleague participation in cross-disciplinary forums&learning opportunities, engages colleagues in Straight Talk&Listen exchanges, demonstrates&models adherence to all the Company's behaviors&values, embraces&complies with Principles of Integrity.

Serves as the primary reviewer of global CMC strategic plans and documentation/submissions

REQUIREMENTS:

Extensive years of mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)

Extensive years of people and/or project management experience, serving as a leader of matrixed&technical teams

High level of knowledge of development&commercial activities and cGMP’s to assess technical, scientific®ulatory merits of CMC information, commitments and data to lead teams and/or complex projects.

Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden&improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle.

Advanced understanding of current and emerging regulatory requirements&expectations, criteria for submission&approval globally,&experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.

Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing&Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.

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