Regulatory Affairs Director
5 days ago
Job Purpose:
Leads CMC regulatory activities in the global lifecycle management of biopharmaceutical products. Oversees a team ensuring compliance with company policies and procedures, staff development, and training to deliver roles.
Key Responsibilities:
- Represents the company on regulatory networks and matrix teams, providing strategic direction and guidance to supply chain, quality assurance, third-party contract management, commercial, and wider teams on global projects and key strategic business initiatives.
- Identifies key risks to the business associated with submission strategy and information packages and communicates well-defined risk mitigation strategies to senior management.
- Likely to have direct line management responsibility, coaching, and mentoring staff across CMC RA on lifecycle management in CMC.
- Manages budget and resources for their teams, ensuring compliance with company policies and procedures, staff development, and training to deliver roles.
- Has effective organizational networks, leading, influencing, and motivating staff within and across departments.
- Commercially astute and organizationally aware, able to deal with sensitive and confidential issues, and may participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
- Delivers CMC regulatory strategy to support major inspections or quality incidents.
- Likely to be involved in and lead current, business-critical activities across internal and external networks on behalf of the company, leading the company position to influence the internal/external CMC regulatory environment through specialist areas of intelligence.
- Has accountability for submission content, understanding, interpreting, and advising on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products.
- Directs resources across multiple projects and teams simultaneously to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests.
- Formulates novel approaches and influences people, evaluating and improving CMC regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work.
Basic Qualifications:
- 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 in a variety of settings.
- Experience handling complex global CMC issues through continuous change and improvement.
Preferred Qualifications:
- 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.
- Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
- Identified as CMC Regulatory expert in a specific subject area.
- Proven experience in supervising and training staff within and across the organization.
- Able to demonstrate the following key high-performance behaviors: customer-driven, flexible thinking, and continuous improvement.
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