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Director Regulatory Affairs Manager
11 hours ago
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.
- 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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