Regulatory Affairs Director to BioArctic

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

Are you a senior Regulatory Affairs professional who enjoys shaping regulatory strategy while remaining closely involved in its execution?

BioArctic is looking for a Regulatory Affairs Director to join its team in Stockholm. You will work with innovative drug development programmes in a research-intensive biopharmaceutical company, collaborating with experienced colleagues across R&D and clinical development, as well as coordinating post approval activities for Leqembi in the Nordic region.

The role

You will take regulatory responsibility for one or more development programmes, from early development through later clinical stages and lifecycle management. As a member of global project teams, you will contribute to development strategies, evaluate regulatory options and drive regulatory activities forward.

Your responsibilities will include:

• 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.

The position combines strategic regulatory leadership with hands-on responsibilities. You will get considerable independence, varied regulatory challenges and opportunities for professional development. The specific projects and scope will depend on your background and BioArctic's needs.

The role is based in Stockholm, with on-site presence preferred. Flexibility and the precise seniority of the position may be discussed for the right candidate.

Your background

We are looking for an experienced regulatory professional with a strong track record in clinical drug development and the ability to independently lead regulatory strategies and activities.

Required 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.

Additional merits:

• Experience in the development of biological medicines is highly meriting.
• Experience of orphan drug development and expedited regulatory pathways.
• Nordic regulatory responsibilities for marketed products.
• Experience from smaller, research-driven pharmaceutical or biotech companies.
• Experience of medical devices, combination products or companion diagnostics.
• PhD in a relevant scientific discipline.
• Swedish language skills.

Who you are

You combine scientific curiosity and sound regulatory judgement with a pragmatic, solution-oriented approach. You are comfortable discussing complex regulatory questions, challenging assumptions and presenting alternative strategies with their respective risks and benefits.

You work independently, but value input from colleagues across disciplines. You are structured, proactive and equally comfortable with strategic discussions and detailed regulatory work.

About BioArctic

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases.

The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic’s partner Eisai, who are responsible for regulatory interactions and commercialization globally.

In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport therapies across the blood-brain barrier to enhance the efficacy of the treatment.

BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. BioArctic’s head office is located in Stockholm Sweden, and the company has more than 150 employees.

For further information, please visit www.bioarctic.com