Regulatory Affairs Manager - Nordic Infucare
Are you a communicative and detail-oriented person with the drive to navigate the complex landscape of regulatory and marketing compliance?
Now you have an opportunity to join a dedicated and committed Regulatory, QA & PV team under expansion which is a key function within the Medical department at Nordic Infucare. To succeed in the role as Regulatory Affairs Manager, you should enjoy working in a small and fast-moving company with an agile approach and very strong and caring employee culture. In addition, you need to be positive, open minded and enjoy communicating and interact cross-functionally. The role is reporting to the Head of Regulatory Affairs, Quality Assurance and Pharmacovigilance.
The company started in 2004, acquired by Air Liquide in 2013. Over the years, Nordic Infucare has built up extensive expertise and market presence in the areas of diabetes, cardiology and pulmonology, neurology, and immunology. The company has maintained its innovative and creative spirit and has become a leading Nordic provider of home infusion therapy for patients suffering from chronic diseases.
Read more at nordicinfucare.com.
Main Responsibilities:
Regulatory Strategy Development:
- Supports the company organization with regulatory strategic knowledge.
- Assist with the development of standards for the company’s operating procedures.
Policy Monitoring:
- Keep up to date with relevant regulations and provide recommendations to the leadership team.
- Supports the company in implementing new requirements accordingly.
Cross-functional Collaboration:
- Support and ensure review and management of internal approval of marketing material, from a regulatory point of view (varies a lot but in peak periods it can be 60% of the workload).
Communication with external partners:
- Main contact for partner companies and competent authorities in matters of regulatory for both medicinal products and medical devices.
- Prepares and submits applications and reports to applicable regulatory agencies as requested by the MAH/product suppliers. Responds to requests for information from regulatory bodies.
- Assist MAH/product supplier with local linguistic and regulatory review of product texts (SPC and PIL) and artwork.
Qualifications & Skills:
- MSc of Pharmacy or other relevant degree in natural sciences.
- Minimum 2 years of experience from Regulatory Affairs.
- 2-5 years’ experience within marketing compliance.
- Strong knowledge of regulations for medicinal products and/or medical devices.
- Excellent communication and interpersonal skills.
- Proven ability to lead regulatory submissions and interactions with regulatory agencies.
- Fluent in Swedish and English.
- Merit: Experience from both MedTech and the pharmaceutical industry.
Welcome to apply via haegercarlsson.com
Questions are answered by
Pernilla Sjöstrand, +46(0)70-433 84 46, pernilla@haegercarlsson.com
Julia Erginöz, +46(0)70-864 77 17 julia@haegercarlsson.com
- Avdelning
- Regulatory Affairs
- Roll
- Regulatory Affairs Manager
- Platser
- Stockholm
Kollegor
Om Haeger & Carlsson | Executive Search & Interim AB
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Regulatory Affairs Manager - Nordic Infucare
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