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CMC Regulatory Affairs Director
2 months ago
We are seeking a highly experienced and skilled CMC Regulatory Affairs Director to lead our global biopharmaceutical regulatory activities. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support the lifecycle management of our products.
Key Responsibilities- Represent Global CMC Regulatory on regulatory networks and matrix teams, providing strategic direction and guidance to supply chain, quality assurance, and commercial teams.
- Identify key risks associated with submission strategy and information packages, and develop well-defined risk mitigation strategies.
- Lead and manage a team of regulatory affairs professionals, providing coaching and mentoring to ensure their success.
- Manage budgets and resources for the team, ensuring compliance with GSK policies and procedures.
- Develop and implement effective organizational networks, influencing and motivating staff within and across departments.
- Provide commercially astute and organizationally aware leadership, dealing with sensitive and confidential issues.
- Deliver CMC regulatory strategy to support major inspections and quality incidents.
- Lead current business-critical activities across internal and external networks, influencing the internal/external CMC regulatory environment.
- Accountable for submission content, understanding and interpreting regulations, guidelines, procedures, policies, and strategies.
- Direct resources to ensure all appropriate CMC regulatory aspects are delivered to agreed timelines.
- Formulate novel approaches and influence people, evaluating and improving CMC regulatory processes, policies, and systems.
- BSc in Life Sciences or related scientific discipline with 5+ years of post-approval CMC regulatory experience for biopharmaceutical products.
- Experience in leading major post-approval filing activities for biopharmaceutical products.
- Experience in biopharm drug development and manufacturing and supply processes.
- Experience working with complex worldwide CMC regulatory requirements.
- Project management skills.
- Effective influencing and negotiating experience with regulatory agencies, industry bodies, and personnel within the company.
- Experience handling complex global CMC issues through continuous change and improvement.
- PhD in Life Sciences or related scientific discipline.
- Life cycle management experience, ideally including previous roles within pharmaceutical and/or vaccines product support.
- Demonstrated ability to influence the global internal/external regulatory environment in the biopharm space.
- Continued professional growth in global regulatory affairs, including communication of evolving/emerging trends and policies.
- Proven experience in supervising and training staff within and across the organization.
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive.
