Senior Regulatory Affairs Manager, Stockholm
An exciting opportunity is available for an experienced professional to join a rapidly growing global probiotic company based in Sweden as our Senior Regulatory Affairs Manager. The position is based in Stockholm.
Define appropriate regulatory strategies for designated markets and develop network of local regulatory competency on those markets. Work proactively to secure successful product registration, commercialisation and lifecycle management of designated partners.
Acquire and maintain knowledge regarding applicable legislation within appointed key markets by way of networking. Provide and standardize regulatory information to partners. Develop efficient and sustainable way of work in relation to partners registrations process.
- Acquire and maintain expert knowledge regarding applicable food and food supplement legislation within EU.
- Acquire and maintain knowledge regarding applicable legislation within appointed key markets by way of networking.
- Contribute to development of appropriate regulatory processes and systems
- Providing relevant regulatory documentation to partners.
- Standardization of regulatory documentation to partners.
- Directing activities towards easier regulatory pathways in order to shorten time-to-market.
- Responsible for regulatory knowledge and positioning in appointed projects.
- Responsible for providing regulatory requirements to raw materials.
- Keep track of regulatory documentation sent to partners.
- Collecting data and analysing the regulatory path for different markets and product types.
- Cross-functional communication with regards to relevant regulatory matters.
- Regulatory investigations as appointed.
- Actively collaborate within the RA team to align processes and systems in an efficient manner
- Master of Science or equivalent
- Work experience from Regulatory Affairs.
- Knowledge of cGMP and/or ISO 22000 compliance and regulations.
- Excellent written and verbal communication skills in Swedish and English.
- Creative problem solving skills and a ‘can-do’ attitude.
- Experience from pharmaceutical industry
- Experience from international and cross-cultural environment
The position may be based either in Stockholm.
If you want to learn more about the position, please contact Catharina Bergold at Rekryteringsspecialisten, tel 070-2179879 or firstname.lastname@example.orgApply here
BioGaia's products are sold through around 80 local distribution partners in 100 countries around the world.
To date, 217 clinical studies using BioGaia’s human strains of Lactobacillus reuteri have been performed on 18,000 individuals of all ages. (January 2020)
We have a clear strategy and have set the goals and priorities for 2020. Our sustainability initiatives have been given structure and a long-term approach.