REGULATORY AFFAIRS MANAGER TO SCANDINAVIAN BIOPHARMA

Are you interested in working in an exciting Swedish research-based specialty biopharma company determined to give people all over the world a longer and better life?

Scandinavian Biopharma is developing the first vaccine against ETEC which causes diarrhoea in both travellers and endemic populations. We are now looking to recruit a Regulatory Affairs Manager to the company.

In this exciting role, you will have the opportunity to apply your regulatory expertise within many areas during development, with a focus on regulatory CMC (Chemistry, Manufacturing, and Controls). You will be offered a dynamic and stimulating work environment and collaborate cross-functionally with both internal and external experts. At Scandinavian Biopharma, we are a dedicated, experienced and friendly team with an exciting journey ahead. If this sounds interesting to you – come join us!

The position is full-time and based in Solna. The Regulatory Affairs Manager reports directly to the VP of Regulatory Affairs at the company. We evaluate candidates continuously and welcome your application today!

Main responsibilities

- As regulatory CMC expert coordinate the regulatory strategy for the development and implementation of changes in the manufacturing process including changes in the manufacturer (drug substance and drug product)

- Together with subject matter experts (SME) develop regulatory documents related to the manufacturing (e.g. IMPD, Module 3, Briefing Document)

- Coordinate and compile regulatory submissions for FDA, EMA and national authorities in third world countries (IND, CTA, RtQ etc)

Key qualifications

- Minimum MSc or equivalent degree with + 5 years’ experience in Regulatory Affairs

- Experience of working with projects in development

- Experience of working with biological pharmaceutical products (biologics)

- Excellent communication skills in speech and writing (English and Swedish)

- Experience of working with vaccines and/or WHO prequalification is a plus

The ideal candidate for this position is well-organized, result-oriented and has excellent attention to detail. Strong communication, time-management and problem-solving skills are required to be successful in this role. Furthermore, we believe that you are service-minded and able to work pro-actively and independently.

We are a dedicated team with different competencies in an entrepreneurial company where everyone supports each other to create a positive atmosphere. We are looking forward to having you in our team!

About the company

Scandinavian Biopharma is a research-based specialty biopharma company determined to give people all over the world a longer and better life. We are developing the first vaccine for protection against diarrhoea caused by ETEC in both travellers and endemic populations. We distribute a wide range of specialty biopharma products with focus on vaccines and immunoglobulins.

Scandinavian Biopharma has all the key competences for a successful vaccine development and distribution business. The management has been responsible for the development, manufacturing, registration and global launch of new vaccines, as well as running significant global operations within several biotech and big pharma companies.

Scandinavian Biopharma has a senior commercial team with more than 20 years of experience from biotech, big pharma and the medtech industry. We are well funded thanks to support from EU strategic research foundations Horizon 2020, PATH, USAMMDA and our own distribution activities. To learn more about the company, please visit: http://www.scandinavianbiopharma.se

For more information about this position, please contact:

Krishan Johansson Haque, PhD

Recruitment Consultant, QRIOS Life Science & Engineering

T: +46 72 070 16 53

E: krishan.johansson-haque@qrios.se