Beschreibung
Manager Regulatory Affairs - Swiss Affiliate (m/f)
Reference: -en
Start: ASAP
Duration: 6 MM++
Main tasks:
- Manages or contributes to regulatory submissions to local Health Authority (HA), including assisting with/leading key aspects of initial MA application, assisting with/leading variations, safety reports, risk minimization measures, license renewals as well as clinical trial applications and amendments
- Ensures compliant labeling for medicinal products and manage timely updates for assigned product(s)
- Support country/national scientific advice and / or pre-submission meeting preparation and follow-up
- Contributes to strategic regulatory advice, as appropriate
- Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility
- Supports maintenance of GDP license and Quality Agreements, as required
- Support the management of quality defects, falsified or counterfeit products, batch recalls and stock out as required
- Deputy Responsible for promotional material review / approval if applicable for assigned product(s)
- Supports local Affiliate, regional, Intl or Global RA teams on Affiliate matters
- May support risk assessments on specific local regulatory issues
- Helps prepare the Company for major changes in regulatory legislation and competitor information in the country for assigned product(s) or projects and communicates this internally to stakeholders
- Represents Regulatory Function at internal and external meetings or internal working parties
- Manage or support work in additional countries eg distributor markets as required
- Work is performed with minimal immediate direction from a senior RA professional
- May contribute to training or coaching of staff on key regulatory activities and updates under the direction of a senior RA professional
Main qualifications
- Profound experience in RA or other relevant industry experience with BS/BA or experience in RA or other relevant industry experience with advanced degree. Degree in a scientific field is preferred
- Good knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate
- Must be capable of developing and implementing regulatory initiatives and managing negotiations with the HA
- Knowledge in quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access is advantageous
- Experience in working and leading project teams
- Good working knowledge regarding country/national and regional HAs (people, system, processes and requirements) essential
- Excellent verbal and written English & German language skills
Main advantages:
- A very renowned company
- You will work in an international environment
About us:
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:
Andrea Beck
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