Regulatory Affairs Manager (m/f/d)

REFERENCE NUMBER:

465094/1

MY DUTIES:

- New MA registrations - provide RA input for launch strategy aligned with commercial plan for timely submissions/approvals and management of national phases of Swiss Procedures and maintain relevant knowledge of company’s pipeline in relevant Therapy Area Units 
- Collaborate with Market Access team on the evidence generation and value proposition strategy including preparation of the Pricing and Reimbursement Dossier and follow up Renewal applications. 
- Due diligence for locally in-licensed products from RA perspective including support for MA Transfers
- MA lifecycle maintenance incl. renewals, variations (CMC and non-CMC), labeling updates, blue box requirements, PSUR/PBRERs and etc and ensure national registrations are aligned with global dossier updates and take ownership of regulatory strategies for country specific National registrations
- Provide relevant local impact assessments for global dossier changes and initiate change requests for national licenses as per change control processes.
- Manage compliance of labelling (and mock-ups) with CCDS (incl. updates for generics if originator product changes)
- Local translations of SmPC, labelling, patient information and distribution to internal and external stakeholders (incl. public lists, websites)
- Maintain Global and Local Regulatory databases to ensure accurate records of Regulatory activity and data archives as a key priority
- Contribute to Regulatory Intelligence, stay up to date on local and EU laws and assess the impact on local business and products
- Compliance with EU and local laws and internal processes including EU Food Supplements, Medical Devices, Cosmetics Directives
- Build relationships with Health Authorities, understand their internal workings, maintain open communication channels and respond with urgency and accuracy to Health Authority requests
- Active involvement and participation at Industry Associations
- Budget planning, managing RA contractors/CROs and oversight of outsourced RA activities in agreement with RA Switzerland Lead and responsible for release of promotional materials and their monitoring for conformity and compliance with regulatory requirements

MY QUALIFICATIONS:

- Passionate and self-confident
- Ability to work under pressure
- University degree in Pharmacy or other scientific studies
- Profound experience in RA
- Rofound experience in pharmaceutical industry
- In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry
- Fluent written and spoken German and English / additional national language is a plus (French / Italian)

MY BENEFITS:

- Reputable / modern company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Yves Fabien Deschamps

Reference number
465094/1

Contact
E-Mail: [email protected]