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WD1144115 - Director, CMC Regulatory Affairs (Biopharm/Cell & Gene Therapy)

Job Details

  • Permanent, Full Time
  • Hertfordshire
  • Closes 20th November 2017
  • Requisition ID: WD144115
  • Required degrees: Bachelors
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Basic qualifications:

• Biological sciences degree.
• CMC Regulatory leadership experience with biological medicines (therapeutic proteins and/or cell & gene therapies).

Preferred qualifications:
• MSc. or PhD.
• Line management experience.
• Cell & Gene Therapy regulatory experience covering clinical studies and marketing applications.

Details:
We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer.

Since 2009 we’ve had more new medicines approved than any other healthcare company, including treatments for asthma and COPD, HIV and cancer. We also have many potential new medicines and vaccines in development. This didn’t happen by accident. We’re making progress because we’ve recognized the challenges we face and tackled them head-on – confronting our own assumptions and changing the way we do things. Our continued success depends on our relentless drive to innovate and to widen access to our medicines, vaccines and consumer healthcare products, especially in hard-to-reach areas of the world.

CMC Regulatory Affairs

Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and Global Manufacturing and Supply to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and Advanced Manufacturing Technology for multiple modalities for small and large molecules through to Cell and Gene Therapy

The Director will lead key, strategic CMC regulatory activities for investigational and/or commercial biopharmaceutical (therapeutic protein and cell & gene therapy) products.

Scope of Responsibility:
o Will serve as a key strategic partner representing Global CMC Regulatory, on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and CGT R&D, Global Manufacturing and Supply (GMS), Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
o Likely to have direct line management responsibility.
o May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
o Delivers CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).
o Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK.

Impact of Decisions:
o Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biopharmaceutical products, to expedite submission, review and approval of global CMC applications.
o Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
o Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum GMS flexibility with minimal unanticipated questions.
o Directs resources to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.

Problem Solving:
o Directs project activities and strategies for multiple projects and teams simultaneously, including those for reporting staff as appropriate. Provides strategic direction, data assessment and conclusions to senior management.
o Formulates novel approaches and influences people, systems and processes.
o Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies.
o Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies and systems.
o Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work.

Closing date, Monday 20th November 2017.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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