Regulatory Affairs Director — Biopharma Strategy & Submissions

BioArctic AB; Stockholms kommun; On-site; SEK 1,800,000 - 3,000,000; Full time

Job summary

BioArctic AB in Stockholm seeks an experienced Regulatory Affairs Director to lead regulatory strategy and execution for one or more drug development programmes. You will drive submissions, coordinate interactions with health authorities, and influence global development plans as part of a cross-functional team.

Based in Stockholm with on-site presence preferred, you will interact with Nordic regulatory activities for Leqembi and work with a broad development portfolio in a research-intensive

Qualifications

• Extensive Regulatory Affairs experience in drug development and lifecycle.
• Strong knowledge of EU and international regulatory requirements and procedures.
• Hands-on experience with clinical trial applications and health authority interactions.
• Experience with cross-functional development teams and external collaborations.
• Excellent English communication.

Responsibilities

• Develop regulatory strategies and input to development plans.
• Lead regulatory submissions (CTAs, INDs, briefing packages).
• Coordinate health authority interactions and scientific advice.
• Assess regulatory risks and recommend strategies.
• Collaborate with cross-functional teams and external partners.
• Support Nordic regulatory activities for Leqembi in collaboration with Eisai.

Skills

Regulatory strategy

Regulatory submissions

Health authority interactions

Cross-functional work

English communication

Education

University degree in a relevant scientific discipline

Job description

BioArctic AB in Stockholm seeks an experienced Regulatory Affairs Director to lead regulatory strategy and execution for one or more drug development programmes. You will drive submissions, coordinate interactions with health authorities, and influence global development plans as part of a cross-functional team.

Based in Stockholm with on-site presence preferred, you will interact with Nordic regulatory activities for Leqembi and work with a broad development portfolio in a research-intensive