Director GRA Solid Tumors (gn)

For an international, EU based pharmaceutical company with a broad product portfolio, we are currently looking for a Director Global Regulatory Affairs to head a team within the oncology division and act as a Regulatory Lead.

 

Client:

Our client is a global health care organization with a diversified portfolio of prescription and non-prescription medicines, medical devices and in vitro diagnostics.
The R&D organization within the company is currently building a new pipeline of innovative compounds that will help to address unmet medical needs and improve patients’ lives.
To this purpose they are striving to create an environment of teamwork with talented and dedicated colleagues where integrity, knowledge and imagination are the key values for success.

 

Benefits:

  • Global company with international setting
  • Very strong oncology pipeline with ongoing filings and launches
  • Attractive and flexible salary package according to local requirements, including remote work

 

Job description:

  • Reporting line to Head, Global Regulatory Affairs Oncology within the  Corporate Direction  Regulatory Activities and Market Access.
  • As part of the Global Regulatory Affairs Oncology team, directly manage and provide leadership and mentorship to a team of regulatory representatives responsible for the assigned products.
  • As active member, participate in multi-disciplinary teams in order to define the development and regulatory strategies of early and late stage development programs. Identify and communicate potential risks associated with different strategy scenarios.
  • Contribute to the development of the Target Product Profile in collaboration with other R&D functions.
  • Represent and coordinate regulatory information as a team member, covering clinical, labelling, protocols, reports, presentations, and other documents.
  • Coordinate the preparation, review and submission submissions as required, including marketing applications.  Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions.
  • Manage submission plans and timelines to ensure approvals and development objectives are timely met.
  • Review and analyse competitors’ information, recent product approvals local public Advisory Committee proceedings and global Agencies’ guidelines, to support the development of strong regulatory strategies.
  • Regulatory review of potential in-licensing opportunities and participation in regulatory due diligence activities.
  • Document regulatory contacts with Health Authorities.
  • Manage regulatory data and information within systems.

Für nähere Informationen kontaktieren Sie bitte: / For more information please contact:

Christian Rommerskirchen
+49 0)89 212 65 333
rommerskirchen@conqure.de

Kontakt!