Regulatory Affairs Director – Strategy & Submissions

BioArctic AB; Stockholms kommun; On-site; SEK 1,500,000 - 2,100,000; Full time

Job summary

BioArctic AB (publ) seeks a Regulatory Affairs Director to lead regulatory strategy for development programmes in Stockholm. You will drive regulatory activities across global project teams and coordinate with R&D, clinical development and external partners.

The role combines strategic leadership with hands-on regulatory work, including interactions with health authorities, submissions, and lifecycle management. On-site in Stockholm with flexibility for seniority discussions.

Qualifications

• University degree in a relevant scientific discipline.
• Extensive Regulatory Affairs experience in drug development, with a proven track record as regulatory lead for programmes involving clinical trials.
• Strong knowledge of EU and international regulatory requirements and procedures, including pre- and post-approval frameworks.
• Substantial hands‑on experience of clinical trial applications, regulatory submissions and health authority interactions.
• Experience of working in cross‑functional development teams and managing external collaborations.
• Excellent communication skills in English.

Responsibilities

• Develop regulatory strategies and provide input to clinical development plans.
• Lead and contribute to regulatory submissions, including CTAs, INDs, briefing packages and responses to health authorities.
• Plan and coordinate health authority interactions, scientific advice and applications for expedited regulatory pathways.
• Assess regulatory risks, evaluate strategic options and recommend appropriate approaches.
• Work closely with cross-functional teams and coordinate international regulatory consultants and partners.
• Support Nordic local regulatory activities for Leqembi in collaboration with Eisai.

Education

University degree in a relevant scientific discipline

Job description

BioArctic AB (publ) seeks a Regulatory Affairs Director to lead regulatory strategy for development programmes in Stockholm. You will drive regulatory activities across global project teams and coordinate with R&D, clinical development and external partners.

The role combines strategic leadership with hands-on regulatory work, including interactions with health authorities, submissions, and lifecycle management. On-site in Stockholm with flexibility for seniority discussions.