Senior Regulatory Affairs
Company: Edelway Switzerland AG
Closing Date: 10 Feb 17
Type: Full Time
Salary (£): On Application
We are now looking for a Senior Regulatory Affairs to join a global client in Switzerland.
As a Senior Regulatory Affairs your key role shall be to find innovative solutions for increasing the value of our client’s scientific evidence packages, further developing intra and inter departmental collaboration and ultimately improving speed to market.
- Provide regulatory guidance in the markets of interest, as well as support local markets in the region in terms of submissions and enquiries from regulatory authorities;
- Participate in regulated cross-functional activities related to the client’s product, including but not limited to: risk management, change management, labelling management, and post-marketing surveillance;
- Ensure the timely and accurate preparation, compilation, review and publishing of regulatory dossiers in compliance with local regulatory requirements and our client’s internal standards, in support of clinical studies, market-specific regulatory engagement activities, and marketing authorizations;
- Remain updated of current and new legislation in the European Union. Follow and analyze the applicable regulatory requirements to provide input on all regulatory aspects of relevance;
- Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management.
- University degree in regulatory affairs, health sciences or life sciences;
- Solid experience in regulatory affairs for therapeutic products (pharmaceuticals, medical devices, or combination products) or other strictly regulated products (functional foods, cosmetics, modified-risk tobacco products) in the European Union;
- Regulatory experience with drug delivery systems for inhalation is an asset;
- Expertise in regulatory submissions in the European Union for therapeutic products, or similar, with knowledge of electronic document management systems for regulatory dossiers;
- Excellent writing skills. Proficiency in Word/PowerPoint/Excel;
- Strong communication/negotiation skills, with both internal and external stakeholders;
- Fluency in English (both written and oral). Any additional European Union languages are an asset.