Director Regulatory Affairs Manager

11 hours ago


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

Haeger & Carlsson Executive Search & Interim AB

We are partnering with a renowned life sciences company to find a highly skilled Director Regulatory Affairs. As a key member of the leadership team, you will develop and execute global regulatory strategies to support the submission and approval of biologics.

The ideal candidate has a proven track record in leading regulatory submissions, including Biologics License Applications. They possess extensive knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.

Key Responsibilities:

  • Develop and execute global regulatory strategies to support biologics submission and approval.
  • Provide guidance on regulatory pathways for marketing authorization and applications such as Biologics License Applications.
  • Lead preparation, submission, and negotiation with agencies like FDA and EMA.
  • Support submission activities including BLA filing and briefing documentation for meetings.
  • Lead a small team of in-house regulatory professionals.
Qualifications:
  • 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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