Disease Area Head

Location Ghent Zwijnaarde, United Kingdom
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 10739
Published: 20 days ago

You will be leading a small team of Global Regulatory Team Leads (GRTLs) within the MS/Neurology and Immunology & Inflammation (I&I) Global Regulatory Affairs (GRA) team.

YOUR RESPONSIBILITIES

  • Development and review of regulatory strategies and regulatory “deep-dives”
  • Review of regulatory submissions and brief senior members on the review committee on regulatory strategy
  • Oversee preparation of regulatory presentations for internal governance meetings
  • As a membear of the GRA global management team, be a driver and contributor to regulatory initiatives to improve strategic capabilities and operational excellence
  • Exemplify the core values and guiding principles of GRA
  • Coach and mentor GRTLs in their roles on global project teams and as leader of the global regulatory team
  • Establish a network of internal stakeholders and develop a close working relationship to ensure that GRA is recognized as a valued strategic partner in the development and commercialization of products
  • As needed, function as GRTL being the direct responsible for one of the products under responsibility

 

YOUR DETAILS:

  • Degree in Life Sciences
  • Advanced degree is preferred (MS/PhD/PharmD)
  • 10-15 years industry experience, with at least 10 years working in regulatory affairs (regionally or globally)
  • Management experience of a small team is preferred
  • Delivery of a number of major applications (NDA/BLA/MAA/JNDA etc.)
  • Experience with late stage development projects is preferred and experience with marketed products is required
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
  • Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
  • Prior experience in Immunology is preferred

 

OFFER:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
  • An individual and well-structured introduction and training when you onboard.
  • Your professional and personal development will be supported purposefully.
  • As a globally successful and constantly growing company, we provide international career paths as well.

 

INTERESTED?

For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.