Director Vaccines Development CMC
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
Manage a team of CMC regulatory scientists responsible for providing CMC regulatory strategy and submission support to a specific asset of development products with the goal to secure regulatory approvals for clinical trial and marketing application approvals worldwide.
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:
- Option 1: UK or Italy – candidates should be based in those locations
- Option 2: Waltham, US – candidates should be based in the Massachusetts state and have the right to work in the US.
Basic Qualifications:
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:
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)
Identified as CMC Regulatory expert in a specific subject area
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 intelligence
Formulates novel approaches and influences people, systems and processes
Able to deal with sensitive and confidential issues
Application closing date: Friday June 14th, 2024 EOB
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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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