Director Vaccines Development Cmc
4 settimane fa
**Site Name**: Belgium-Wavre, Italy - Siena, UK - London - Brentford, USA - Massachusetts - Waltham
**Posted Date**: May 27 2024
**Job purpose**:
As the Director Vaccines Development CMC you,
- Are responsible for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy and deliverables for a specific asset of vaccine development products, including in-licensed assets, through to commercial approval
- Provide CMC Regulatory advice to CMC specific boards (e.g. CMC Expert Panel, specification committee)
- Establish and direct appropriate agency CMC communications including End of Phase 2, Pre BLA, Scientific advice and ad-hoc product specific agency dialogue
- Ensure risk assessments are conducted and appropriate mitigation and treatment plans are defined for product developments, effectively liaising with business partners and customers across Technical Research and Development (TRD), Global Industrial Operations (GIO), Global Regulatory Affairs (GRA) and vaccines product development teams
- Provide appropriate CMC RA representation and input to product specific inspections for CMC aspects to secure approvals of new products and ensure GSK learning and continuous improvement.
**Your responsibilities**:
- Provide leadership and direction to CMC regulatory scientists within their team, including management of workload and priorities
- Together with line management, recruit, retain and develop CMC regulatory scientists (Senior Managers, Managers and/or Specialists) so to achieve quality output (”Right First Time”), accountability and recognition across the Organization
- Develop CMC Subject Matter Experts network and sharing of expertise across their team and together with other CMC regulatory units across GRA and beyond
- Accountable for CMC regulatory affairs representation to specific CMC development Teams (e.g. TDT, CMC expert panel, specification committee), thus ensuring CMC regulatory strategy, scientific and procedural input required for advancement of the Vaccine development program assigned to their team
- Accountable for defining the CMC regulatory submission strategy for their specific development asset; to be done in partnership with Global Regulatory as required
- Accountable for the preparation, authoring and timely submission of high-quality CMC development dossiers (e.g. CTA, IMPD, IND), including interactions with and management of contributing departments within GRA (e.g. content delivery) or outside (TRD, Quality, manufacturing etc)
- May act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
- Provide support to the Global Regulatory Lead (GRL) for key CMC regulatory activities pertaining to a development product (e.g. attendance to VDT if required, CMC input for Global Regulatory Plan, etc) and to product registration to achieve on-time approvals of GSK Vaccines submissions for the asset(s)
- Delivers CMC regulatory strategy to support major inspections (e.g. PAI's or quality incidents (PIRCs).
**Additional information**:
- Reporting line: Director Vaccines Development Projects
- Number of positions available: 2
- People management: 6 to 9 direct reports
- Business travel requirements: 2 travels/year max. to the US or to Singapore
- Primary location: Wavre, Belgium
- Secondary locations:**_ Why You?_**:
**Basic Qualifications**:
- We are looking for professionals with these required skills to achieve our goals:_
- Minimum Master’s degree level in Sciences or Medical Sciences
- Demonstrate knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise
- Demonstrate knowledge of complex worldwide CMC regulatory requirements and ability to influence the global internal/external regulatory environment
- Project management and multi-tasking skills
- Ability to handle complex global CMC issues through continuous change and improvement
- Demonstrate effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings
- Proven experience in supervising and training teams - onsite and remote teams
- Fluency in English both written and spoken
**Preferred Qualifications**:
- If you have the following characteristics, it would be a plus:_
- Master’s degree or higher level in Chemistry, pharmacy, biological or closely related science advanced degree
- 8+ years in Pharmaceutical industry or Research organizations, with 5+ years in Regulatory Affairs and with demonstrated experience of team leadership
- Regulatory Affairs Certification (RAPS)
- AI exposure
- Able to demonstrate the following key high-performance behaviors: decisive, customer driven, flexible thinking, smart-risk taking and continuous improvement
- Leads, influences and motivates staff within and across departments
- Leads the company position to influence the internal / external CMC Regulatory and/or Global Industrial Operations, Quality, R&D environment through specialist areas of int
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