Global Regulatory Strategy Lead

11 hours ago


Stockholm, Stockholm, Sweden Haeger & Carlsson | Executive Search & Interim AB Full time

Executive Search & Interim AB - Partnering with Haeger & Carlsson

We are seeking a seasoned Regulatory Affairs Director to join our client's dynamic team. In this pivotal role, you will drive global regulatory strategies to ensure the timely submission and approval of biologic products.

The successful candidate must have a strong background in regulatory affairs, with expertise in leading regulatory submissions, including Biologics License Applications. Additionally, they should be well-versed in global regulatory requirements, including FDA, EMA, and ICH guidelines.

Key Objectives:

  • Develop and implement global regulatory strategies to support biologics submission and approval.
  • Provide strategic guidance on regulatory pathways for marketing authorization and applications.
  • Lead the preparation, submission, and negotiation of regulatory documents with agencies like FDA and EMA.
  • Oversee submission activities, including BLA filing and briefing documentation for meetings.
  • Lead a small team of regulatory professionals.
Requirements:
  • Life Sciences Degree or equivalent.
  • Minimum 10+ years of Regulatory Affairs experience in the biotech or pharmaceutical industry.
  • Proven experience in leading regulatory submissions, including Biologics License Applications.
  • Extensive knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
  • Experience in global product launch preparation and post-approval regulatory management.
  • Highly proficient in spoken and written English.


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