WE ARE NO LONGER TAKING APPLICATIONS FOR THIS POSITION
This position is open at our offices in Oslo, Norway.
LINK Medical is searching for a Regulatory Manager. Our company is growing, and the portfolio of cross-functional projects is increasing. As a Regulatory Manager, you will work in close collaboration with members of several project teams and members across the LINK Medical organization.
We are seeking highly motivated team player to join our team of regulatory experts. As a consultant in LINK Medical you will deliver high quality services in accordance with our customer expectations. You will have the opportunity to develop your competence according to our customer needs and participate in activities related to business development.
The position may include outsourcing to customers in the greater Oslo area.
Responsibilities
- Complete projects/services according to the agreement with project manager, line manager and customer
- Ensuring customers’ positive perception of the collaboration with LINK Medical
- Regulatory support, e.g. consultation and advice on national legislation and specific requirements
- Prepare and maintain dossier documentation in accordance with applicable regulatory requirements
- Interact with Competent Authorities to the extent required.
- Contribute to the development of your area of expertise within LINK Medical
- Cooperate with colleagues in LINK Medical, nationally and internationally
- Contribute to the continuous improvement and securing best practices within LINK Medical
Responsibilities Pre-marketing
- Perform Gap Analysis of customers pre-clinical documentation
- Perform Target Product Profile workshops
- Provide Regulatory Strategy to customers
- Medical Writing
- Scientific Advice meeting
- Clinical trial application (CTA)/ Investigational New Drug (IND) support
- New Drug applications NDA/Marketing Authorisation Application (MAA) Support
- Regulatory pathways and designations
- Project management
Desired qualifications
- Life science degree at college/university level in Pharmacy, Biology, Chemistry, Medicine, Veterinary, Toxicology or similar
- 2+ years of experience within Regulatory Affairs is desirable
- Generally good IT skills
- Fluent in Norwegian and English (written and oral)
In addition, we are interested in people for the pre-marketing position with some of the following capabilities:
- Knowledge in basal pharmacology, cell therapy, or pharmacotoxicology
- Preclinical and clinical development in pharmaceutical or biotech industry
- Experience from working with quality standards like GMP, GLP, GCP, ICH etc.
Personal characteristics
- Delivering results and meeting customer expectations
- Working systematically
- Planning and organisational skills and ability to prioritize
- Following procedures and instructions
- Keeping timelines
- Team player and people oriented
- Engaged and motivated
LINK Medical offers
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive compensation and benefit scheme for all employees.
Contact information
If you would like to know more or have any questions regarding the positions, please contact Hiring Manager
Marit Erlien, Group Manager, Regulatory: +47 94 28 96 98, marit.erlien@linkmedical.eu
All applications are treated confidentially. Local applicants will be prioritized.
Last day for application: 2022-DECEMBER-11
