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PhD in Life Sciences, Pharmacist or equivalent as Head of Regulatory Affairs (m/f)

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Job Description: Head of Regulatory Affairs (RA)

Main function:
Oversee and lead all regulatory affairs activities concerning the development and global registration of Biosimilars. Assure that new biosimilar products are developed in line with the global registration requirements of all target countries. Additional key responsibilities of this exciting position are the set-up of an own regulatory affairs team and pro-actively managing of interfaces with regulatory affairs teams of partner companies.

Most important tasks of the job:
  • Define regulatory strategies for development projects
  • Represent the RA group as a member of cross-functional development teams
  • Lead cross-functional assessment of regulatory risks for development products and ensure successful review by regulatory authorities
  • Lead the preparation of registration packages and alignment with internal development functions (CMC, clinical, etc.) as well as co-development partners
  • Verify regulatory feasibility for product development strategy, preclinical and clinical studies
  • Negotiate submission data requirements with regulatory authorities (globally)
  • Lead the communication with regulatory authorities, act as key point of contact and maintain exceptional relationships
  • Ensure regulatory compliance for all biosimilar products
  • Maintain awareness of global regulatory legislation for biosimilars and communicate potential impact on business and product development programs
  • Ensure strong internal stakeholder relationships with other development functions and the management
  • Supervise a small team of regulatory affairs managers and provide managerial support and training to employees, including remote co-workers
  • Establish employee goals that align with company goals and alliance partner goals
  • Maintain job descriptions, create employee development plans, provide performance feedback and retain regulatory staff members

Prerequisite: The Head RA position is either based in Reykjavik (Iceland) or Basel (Switzerland).

Organisation Structure: The Head RA position reports to the CEO.


Education: PhD in Life Sciences, Pharmacist or equivalent.

  • Minumum of 8-10 year experience in pharmaceutical industry
  • Broad Global Regulatory experience, with a minimum of 5 year experience in EU or US regulatory affairs
  • At least 3 year experience with biologics, ideally with biosimilars
  • Experience working directly with regulatory agencies
  • In-depth knowledge of agency guidances and regulations
  • At least 2 years of direct people management experience preferred
  • Good interpersonal skills
  • Excellent communication and negotiating skills
  • Good understanding of pharmaceutical development and biopharmaceutical business
  • Ability to challenge scientific data
  • Experience with clinical trials
  • Have the ability to work in a complex organization
  • Fluency in English; Knowledge of German languages is a plus
Please submit your applications by November 15th at the latest



Art des Bewerbungszugangs
Please apply only using the "apply online" button

Kontakt für Bewerbungen
Lilja Gudmundsdottir
Director of Human Resources
Please apply only using the "apply online" button


Details der Stellenanzeige

Bereichs- & Abteilungsleitung
Berufserfahrung vorausgesetzt
Island, Schweiz (Basel-Stadt)
4000 Basel
Biologie & Life Sciences, Biotechnologie, Humanmedizin, Chemie, Pharma