Director Regulatory Global Specialty/Biosimilar Development

Director Regulatory Global Specialty/Biosimilar Development

Stada

Bad Vilbel, Germany

What you can expect

  • You define clear roles and responsibilities for individual team members;
  • You define and prioritize individual deliverables across the department, closely aligned with overarching department objectives;
  • You develop individuals and assure the overall team performance;
  • You are responsible for the definition of relevant KPIs for Regulatory department to assure consistent performance tracking;
  • You have the oversight of all regulatory activities incl. Contribution to due diligences if applicable and preparation of regulatory interactions and assurance of delivery of all regulatory documents;
  • You close monitoring of new regulatory trends, guidance and guidelines and translation into potential impact assessment on STADA Specialty and Biosimilar business;
  • You take care of the development and implementation on state-of-the art processes;
  • You are responsible for the identification and implementation of best-in-class tools to support the department and the team;
  • You are the go-to expert for all kind of global & local Regulatory questions Deputy;
  • You are the Deputy of Head Global Specialty Development.

Who we are looking for

  • You have a Master in Life Science, Ph.D;
  • You have 15+ years of experience in Pharmaceutical industry and 8 + years of experience in Regulatory affairs incl. global positions;
  • You have a proven track record of achieving drug approvals from different health authorities, in particular FDA, EMA, Swissmedic, additional experience with e.g. COFEPRIS, ANVISA, PMDA, NMPA, etc. is a plus;
  • You have a broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections, etc.;
  • You have a proven track record as team leader either in line or matrix setting;
  • You bring a Robust understanding of Biologics / recombinant molecules, ideally also Biosimilars with you;
  • You are an experienced user of regulatory intelligence software, publishing tools and document management software (preparation of eCTDs);
  • You are a strong communicator, both verbally and in writing;
  • You are a team player, proven to be successfully working in global and cross-functional environments;
  • Your focus is entrepreneur with proactive and agile working style – resilient in facing ambiguity at the same time efficiently deploying project management skills;
  • You are open-minded and curious to explore new ways of working;
  • You have excellent knowledge in English, any other language(s) as German are a plus.

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