Director Regulatory Affairs

Hansa Biopharma; 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

About us

Hansa Biopharma is a fast‑growing, commercial‑stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life‑altering treatments for patients with rare immunological conditions.

Our broad therapeutic pipeline based on the company’s proprietary IgG‑cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.

By empowering our people and working in an agile way we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.

Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.

Position summary

As Director Regulatory Affairs you will report to the Chief Regulatory Affairs Officer, and will be a part of our Regulatory Affairs and Clinical Reporting department, currently a team of five regulatory and three medical writing colleagues.

You will be playing a pivotal role in developing and executing global regulatory strategies supporting drug development programs, as well as hands‑on work leading regulatory submissions and approvals.

Key tasks and responsibilities

• Lead and contribute to regulatory strategies for assigned projects that expedite development, maximize the probability of success and mitigate risks.
• Play a hands‑on role in planning, preparing and coordinating regulatory documents for submission to global health authorities as part of regulatory filings, such as CTAs/INDs, amendments, annual updates, paediatric investigation plans, orphan drug applications, fast track applications, responses to health authority information requests and BLAs/MAAs.
• Managing and leading the planning and preparation of meeting requests and meeting packages for health authority interactions for assigned projects.
• Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards.
• Provide regulatory leadership and guidance to cross‑functional project teams and lead the development, strategy and execution of regulatory submission documents while working collaboratively with the project team including a variety of personnel and staff.
• Liaise with internal QA and CMC teams ensuring regulatory requirements are consistently met across QA and manufacturing functions.

Education and experience requirements

• Education in the natural sciences space with an MSc degree in Pharmacy, Chemistry or similar.
• Ideally 10+ years’ experience in industry and 7+ years in Regulatory Affairs.
• Experience in preparing regulatory strategies/regulatory development plans, highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments.
• Experience with clinical trial submissions and approvals.
• Previous experience in a senior regulatory role, including health authority interactions, e.g. FDA and EMA meetings is required, and experience with BLA/MAA dossier preparation and submissions is desirable.
• In-depth understanding of regulations and guidelines governing all phases of drug development.
• Highly resourceful team‑player, with the ability to be also extremely effective independently.
• Strategic mindset, innovative yet pragmatic/solution‑oriented thinking, at the same time keen to also work in an operational role with attention to detail.
• Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.

Our culture and values

Working at Hansa is more than a job for us, and our culture is characterised by pride — pride in what we do, in our company, and in what we have achieved and will accomplish for patients around the world.

Our culture is built on our core values: Accountability, Courage, Integrity, and Pioneering. These values guide how we work, collaborate, and make decisions every day.

We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve. Our recruitment policy is simple - hire the best person for the job.

Reasons to join the Hansa Team

• A position in a company that envisions life changing outcomes for patients with immune mediated conditions.
• You will be part of an innovative R&D-driven organisation with a strong desire to make a difference for patients.
• The role is an opportunity to be part of the journey building a fully integrated biopharmaceutical company with a global outreach.
• An open-minded and welcoming atmosphere. Friendly, motivated and skilled colleagues with whom you can both laugh and work.

Type of employment

This is a permanent, full‑time (40‑hours) position based in Lund, Sweden. The role requires regular on‑site presence, with an expectation an average of four days per week in the office.

Start date as soon as possible.