Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

Seagen

Zug, Switzerland

Summary:

Reporting to the Senior Director of EU/RoW Regulatory Affairs, and in accordance with the goals of the company, and applicable regulations, standards, established procedures and planned objectives, the Senior Manager/Associate Director of Regulatory Affairs will be responsible for developing regulatory strategies, and planning, managing and executing regulatory activities for drug products in the EU/Switzerland/UK.

Principal Responsibilities:

  • Develop European regulatory strategies and work with the Senior Director of Regulatory Affairs and global Regulatory team towards the development of global regulatory strategies
  • Provide strategic input to the Global Regulatory Team for all Europe-based Regulatory Affairs matters, including the seeking of Scientific Advice, MAA submissions, ODD, PIPs, as needed
  • Define the strategy for and lead the MAA submission procedures in the EU, Switzerland, UK (post-Brexit) for an NME in oncology
  • Define and execute strategies for regulatory maintenance submissions (amendments, notifications, variations, renewals, annual updates) for drug products in Europe; as needed, work with regulatory affairs consultants/contractors, submit regulatory documentation and act as primary contact with the EMA and EU National Competent Authorities (NCAs) as needed
  • Supervise CTA Manager(s), responsible for CTA submissions/maintenance
  • Serve as a liaison with the EMA and NCAs to support effective collaborations
  • Educate project teams on the European regulatory pathways and requirements to ensure effective product development and registration
  • Maintain an effective archiving system
  • Ensure that the pharmaceutical products distributed in Europe meet EMA/ICH/NCA requirements and support the local commercial organizations
  • In partnership with other regulatory staff, maintain and expand current knowledge of regional regulatory requirements and precedents, including new regulations and laws, that may affect the clinical development and commercialization of company products
  • Provide training on specific regulatory topics
  • Support contractor selection and coordination of contracted activities
  • Performs other duties as required

Qualifications:

  • PharmD, PhD, Masters or Bachelors degree in life sciences
  • Minimum of 7 years of Regulatory experience, with at least 5 years in a similar EU-based strategic role
  • EU Centralized Procedure experience required (preferably an MAA, or as a minimum, major Type II Variations for new indications)
  • Ability to oversee regulatory activities and manage processes from research/discovery, clinical development through commercialization and post-marketing maintenance
  • Experienced with CTA submissions and maintenance, as well as PIPs, Scientific Advice and Orphan Drug Designations
  • Knowledge of EU procedures (fast to market procedures would be an advantage)
  • Familiarity with FDA IND/NDA/BLA, National European (Swiss, UK, others) regulatory processes preferred
  • Line management experience advantageous
  • Regulatory project management experience

Education:

  • PharmD, PhD, Masters or Bachelor’s degree in life sciences

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Switzerland     Clinical Research     Manager and Executive     Regulatory Affairs     Seagen    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies