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 and is 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 and be responsible for our Clinical trial applications and amendments as well contribute to the successful development of regulatory strategies for our clinical trials.
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!


About the position
Main responsibilities for the position include:

- Managing submissions during development (CTA/IND/SA/PIP etc)
- Hands on - preparation of documents (including review/editing), e.g. Module 1 (national) documents, SA Briefing documents, Corporate Data Sheet
- Update of dossiers (IND/IMPD)
- Advice on regulatory matters during development
- Managing submission for MAH products (national)
- Assist in strategic Regulatory Affairs planning and decisions


Responsibilities
Key qualifications include:
- Degree in a Life Science or related discipline (minimum MSc or equivalent degree)
- Several years of experience from the pharmaceutical industry or competent authority (regulatory, development)
- Some years of regulatory experience applicable to the role (e.g. regulatory support of clinical trials such as CTA submissions)
- Knowledge and experience in pharmaceutical development of Biological products (biologics)
- Experience from vaccine products and/or clinical studies in Low- and Middle-Income Countries is a plus
- Fluent in English and Swedish
The ideal candidate for this position is well-organized, result-oriented and has an 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 in order to create a positive atmosphere. We are looking forward to having you in our team!


About the organisation
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. In 2019 the company’s distribution business continued to grow, reaching new record of 84.1 MSEK. The Scandinavian Biopharma group is profitable since 2013
To learn more about the company, please visit: http://www.scandinavianbiopharma.se