Director, CMC Regulatory Affairs Specialist
1 month ago
As a key member of our team, you will lead CMC regulatory activities in the global lifecycle management of biopharmaceutical products. You will be responsible for ensuring compliance with company policies and procedures, staff development, and training to deliver roles.
Key Responsibilities:- Represent Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial, and wider GRA on global project and key strategic business initiatives.
- Identify key risks to the business associated with submission strategy and information packages and provide well-defined risk mitigation strategies to senior management.
- Have direct line management responsibility, coaching and mentoring staff across CMC RA on lifecycle management in CMC.
- Manage budget and resources for teams, ensuring compliance with company policies and procedures, staff development, and training to deliver roles.
- Develop effective organisational (internal and external) networks, leading, influencing, and motivating staff within and across departments.
- Be commercially astute and organisationally aware, able to deal with sensitive and confidential issues, and participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
- Deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (LICs/PIRCs).
- 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.
- Have accountability for submission content, understanding, interpreting, and advising on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements.
- Direct resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests, including transfer of supply within the company or with a 3rd party, are delivered to agreed timelines.
- Formulate novel approaches and influence people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work.
- Operate with independence, directing and communicating complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs, ensuring optimum position for the company.
- 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 (e.g. significant manufacturing change and key regulatory interactions in lifecycle management).
- 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.
- 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 organisation.
- Able to demonstrate the following key high-performance behaviours: customer driven, flexible thinking, and continuous improvement.
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