Regulatory Affairs Consultant

We are seeking an experienced Regulatory Affairs Manager to join our QRIOS Life Science team in Stockholm and one of our clients with a strong brand portfolio focusing on over the counter medicines (OTC) and consumer products within oral care, feminine care, skin health and baby care.

About the position
Main responsibility will be to work with OTC medicines but may also involve working with Cosmetics.
You will join our clients Regulatory Affairs team which is based in Solna and will be offered a flexible work environment.

Responsibilities:
- Support regulatory activities for National and/or European procedures for medicinal products (Decentralised, Mutual Recognition) as appropriate.
- Support regulatory activities for identified Nordic Products and work with Local market Regulatory Colleagues in Norway, Finland and Denmark to ensure work activities are completed in line with the business plan.
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met, for instance prepare, review and compile regulatory submissions and responses to the Health Authorities, work with Product Information (artworks, leaflets and SmPCs).
- Develop and support regulatory strategies (local and regional) in line with business plan.
- Continuously update local/global databases, records, trackers and make sure alignment with compliance processes.
- Input to medical, marketing, supply, complaints and pharmacovigilance activities for products on the Swedish and/or Nordics market.
- Responsible for the communication with the local Health Authority and being key contact person for designated products. Ensure regulatory status of on-going activities is communicated appropriately.
- Support regulatory activities for any Cosmetic products as appropriate.

Your profile
• Experience in Regulatory Affairs working directly with MPA within the pharmaceutical/ Consumer Healthcare industry (required).
• OTC Regulatory Affairs experience and desirable to have a working knowledge of Cosmetic Regulatory Affairs (preferred).
• Proficient in Swedish and English language (required).


About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.
It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.