A growing European Headquartered Global CRO is looking for an enthusiastic and experienced Regulatory Manager to be based in Stockholm. This is a brilliant opportunity to join one of the largest independent CROs who provide flexible solutions whilst providing depth and breadth in multiple therapeutic and scientific areas.
- Responsible for coordinating and submitting applications and post-marketing obligations to the authorities.
- Expert on processes, applications and regulatory environment to achieve and maintain marketing authorisations.
- Providing generalist comments on the content of regulatory applications.
- Regulatory representative in the Core Projects/Products Teams, if applicable.
- Cooperating with authorities, partners, regulatory consultants and other departments within company.
- Developing and updating regulatory SOPs, participate in operational excellence work.
- Providing regulatory input to project and product forecasts.
Skills and Requirements:
- University degree in Life Sciences.
- Experience from pharmaceutical industry or competent authority (registration, development, maintenance). Preferably more than 3 years.
- Regulatory Affairs knowledge.
- Fluency in English, other languages is an upside but not required.
- Strong team-player with collaborative, respectful and flexible attitude and high engagement.
- Able to collaborate with different parties both external and internal.
- Highly self-motivated and able to drive activities.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at 0203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.