Regulatory Affairs Senior Director

Would you like to be part of a global biopharma company? Hansa Biopharma is a global 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: Regulatory Affairs Senior Director

The Regulatory Affairs Senior Director will play a pivotal role in shaping regulatory strategy and collaborating closely with drug development project teams. Working within cross-company development project teams, the Regulatory Affairs Senior Director will leverage his/her expertise to translate clinical, nonclinical, and CMC regulatory requirements into actionable strategic plans. These plans will be implemented through coordination, authorship, and development of drug applications and submissions, as well as through direct interactions with regulatory agencies.

Principal Responsibilities

Assess regulatory requirements and provide strategic input to program teams and upper management.

Plan and execute agency interactions and submissions, communicating requirements and timelines effectively.

Lead the planning, authoring, and compilation of regulatory applications and packages, ensuring timely preparation and publication of submission documents.

Participate in meetings with regulatory agencies to facilitate drug development and approvals efficiently.

Identify relevant guidance documents and standards, provide interpretive guidance, and integrate them into development planning.

Communicate with regulatory agencies regarding development strategies, pathways, and submission clarifications.

Prepare information or responses as requested by regulatory agencies, ensuring scientific rigor, accuracy, and clarity.

Provide technical review of data or reports for incorporation into regulatory submissions.

Review clinical protocols to ensure data collection meets regulatory submission requirements.

Collaborate with Safety and Pharmacovigilance to review safety reports and file required SAE reports.

Review labeling, batch records, and specifications for compliance with regulations and policies.

Maintain regulatory documentation in accordance with Hansa’s standards.

Perform other duties as assigned.

Professional Qualifications

Advanced degree in bioscience is required.

15+ years of industry experience with increasing Regulatory Affairs leadership.

Solid working knowledge of US, EU, and global regulations and guidance.

Successful interactions with global regulatory authorities.

Hands-on experience with IND/CTA, MAA/BLA, and life-cycle management applications.

Ability to lead through influence and facilitate strategy development within cross-functional teams.

Effective management of multiple time-sensitive projects.

Proficiency in written and spoken English.

Experience with orphan drug products is advantageous.

As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:

You are energetic, self-motivated, and hands-on professional with a strong work ethic.

You possess strong facilitative leadership skills.

You are capable of independent problem-solving and analytical thinking.

You have excellent communication and interpersonal skills for internal and external interactions.

You are productive and successful in a dynamic work environment.

You have a willingness to travel up to 20%.

Our culture and behaviours

Working at Hansa is more than a job for us and our culture is characterised by pride. Pride in what we do, in the company and in what we have, and will, accomplish for patients around the world. Our culture is supported and enhanced by our behaviours, and above and beyond professional qualifications and experience, we look for the following behaviours in all our future colleagues:

Self-motivated

Doer

Team player

Our people mean everything to us, and so our leaders, in addition to the above, must also be able to evidence the behaviours below:

Brave

Empathetic

Lead-by-example

All these behaviours will be assessed at various stages of the recruitment process.

Hansa is for everyone

At Hansa we aspire to be a truly great place to work. 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.

What We Offer

A position in a company that envisions a world where patients with rare immunological diseases lead long and healthy lives.

The chance to be part of an innovative organisation with a strong desire to make a difference for people.

An opportunity to build a fully integrated biopharmaceutical company with global outreach.

An open-minded and welcoming atmosphere. We care about our employees and are immensely proud to have been certified “A Great Place to Work” by Great Place to Work, a global authority on workplace culture, employee experience and leadership behaviour.

Friendly, motivated and skilled colleagues with whom you can both laugh and work.

Type of employment

This is a permanent and full-time (40 hours) position.

Hansa Biopharma is based in Lund, Sweden. We offer a hybrid way of working and we would love to be able to meet you in person in the office at least 2-3 days per week.

The process

Please apply for the position through the following link. Applications should not be sent through any other platform.

Attach your CV and a cover letter in English only. Unfortunately we are unable to review applications made in other languages.

This is in an urgent recruitment. We will review applications as they are received.

For questions regarding the position and process, please contact the recruiting manager: Zak Huang, zak.huang@hansabiopharma.com.

We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s research

Please note: No external recruitment support is required. Only applications received directly will be considered.

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