Regulatory Affairs/Compliance Manager/Officer – Sweden
AL Solutions are looking for a Regulatory Manager to work for a market-leading Scandinavian CRO and to be based in Sweden (Uppsala or Stockholm).
This is an opportunity to join a mid-sized organisation that is rapidly expanding and at the heart of innovation. They truly believe in a work-life-balance and have many benefits to evidence this.
The company currently has a headcount of near 200 currently working within clinical development.
- Complete projects/services according to the agreement with project manager, line manager and customer
- Report progress of projects and other services according to agreement with project manager, line manager and customer
- Behaviour according to our promises (quality, punctuality, communication) and values (credibility, focus on solutions, job satisfaction)
- Contribute to the development of your area of expertise
- Main responsibilities Completing task(s) according to applicable regulations, agreements and budget
- Ensuring that defined objectives and plans are met and complied to
- Ensuring customers’ positive perception of the collaboration with
- Active project participation
- Regulatory submissions for approvals of new products, line-extensions; managing the preparation, content and format of the dossier, responding to authority questions for medicinal products
- Driving submissions of variations and renewals
- Liaison with Health Authorities
- Preparation and maintenance of product information
- Review and approval of packaging materials
- Clinical trial applications
- Pharmacovigilance responsibilities
- Occasional Translations, Compliance and other tasks.
- Basic education within relevant field, equivalent to degree from University or University College, formal education may be compensated by experience
- Experience within Regulatory Affairs
- Ability to show initiative
- Ability to work independently
- Knowledge about Pharmaceuticals and Biotech Products
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.al2s3.com or reach out to us via:
Tel: +44 (0) 203 778 0909