Global Regulatory Affairs Director – Lead Submissions

Hansa Biopharma AB; Sweden; On-site; SEK 763,192 - 1,090,275; Full time

Benefits offered by this job

Innovative R&D-driven environment

Friendly and motivated colleagues

Opportunity to impact lives of patients

Job summary

Hansa Biopharma in Lund is seeking a Director of Regulatory Affairs. This role involves developing and executing global regulatory strategies while leading regulatory submissions and approvals.

The ideal candidate will have over 10 years in the industry, with significant experience in Regulatory Affairs. The position requires strong communication skills and a collaborative mindset.

Join us in our mission to change lives for patients with immune-mediated conditions.

Qualifications

• 10+ years’ experience in industry, with at least 7+ years in Regulatory Affairs.
• Experience in health authority interactions, including FDA and EMA meetings.
• Strong strategic and operational mindset with a focus on detail.

Responsibilities

• Lead regulatory strategies for assigned projects to maximize success.
• Prepare regulatory documents for submission to health authorities.
• Coordinate health authority interactions for assigned projects.

Skills

Regulatory strategies

Clinical trial submissions

Communication with health authorities

Team collaboration

Attention to detail

Education

MSc degree in Pharmacy, Chemistry or similar

Job description

Hansa Biopharma in Lund is seeking a Director of Regulatory Affairs. This role involves developing and executing global regulatory strategies while leading regulatory submissions and approvals.

The ideal candidate will have over 10 years in the industry, with significant experience in Regulatory Affairs. The position requires strong communication skills and a collaborative mindset.

Join us in our mission to change lives for patients with immune-mediated conditions.