Job Description:
Director of Vaccine Regulatory Affairs
This is a leadership role that requires the ability to manage key regulatory activities in late development and global lifecycle management of vaccines. The ideal candidate will have a strong background in drug development, manufacturing, and supply processes, as well as experience with complex worldwide CMC regulatory requirements.
Key Responsibilities:
* Strategic Direction: 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 both global project and key strategic business initiatives.
* Risk Mitigation: Identify key risks to the business associated with submission strategy and information packages, and provide well-defined risk mitigation strategies to senior management.
* Team Management: Have direct line management responsibility, coach, and mentor staff across CMC RA on lifecycle management in CMC, manage budget and resources for teams, ensure team compliance with GSK policies and procedures, and develop staff training plans.
* Cross-Functional Collaboration: Navigate internal and external networks, lead, influence, and motivate staff within and across departments, and be commercially astute and organizationally aware.
* Regulatory Expertise: Deliver CMC regulatory strategy to support major inspections or quality incidents, participate in corporate evaluation, and provide CMC regulatory support and advice to in-licensing and divestment projects.
* Submission Content Accountability: Understand, interpret, and advise 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.
Why You?
We are looking for professionals with the following required skills and qualifications:
* High-Performance Behaviors: Demonstrate customer-driven behavior, flexible thinking, and continuous improvement.
* Technical Expertise: Have detailed knowledge of drug development and manufacturing and supply processes, and may have a specialized area of expertise.
* Regulatory Knowledge: Have detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
* Project Management: Proven project management and multi-tasking skills.
* Influencing and Negotiation: Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel within the company in a variety of settings.
* Complex Issue Handling: Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
Preferred Qualifications:
* Life Cycle Management Experience: Ideally have experience in life cycle management, including previous roles within pharmaceutical and/or vaccines product support.
* US FDA Experience: US FDA experience is highly desirable.
* Continued Professional Growth: Continue professional growth in global regulatory affairs, including communication of evolving/emerging trends and policies.
* Capture Opportunities: Identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
* CMC Regulatory Expertise: Identified as CMC Regulatory expert in a specific subject area.
* Supervising and Training Staff: Proven experience in supervising and training staff within and across the organisation.
What We Offer:
* Competitive Salary: A competitive salary package.
* Annual Bonus: An annual bonus based on company performance.
* Healthcare and Wellbeing Programmes: Access to healthcare and wellbeing programmes.
* Pension Plan Membership: Pension plan membership.
* Shares and Savings Programme: Shares and savings programme.
* Hybrid Working Model: A hybrid working model offering flexibility between remote and in-office work.