An internationally leading pharmaceutical company is seeking to recruit a Regulatory Manager at their office in Switzerland. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
- Planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products within clients portfolio in compliance with global filing plans and local regulatory requirements.
- Implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leading the development of regional regulatory documents and meetings in accordance with GRT strategy.
- Providing regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan).
- Directing the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Managing regional label negotiation activities.
- With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives.
- Managing all activities for vaccine compounds in Europe.
- Be involved in all activities including CTD document and module 1.
Skills and Requirements:
- A very detailed orientated and focussed person.
- Good team player.
- Experience in EU regulatory is key along with clinical regulatory.
- Experience in biologics and/or vaccines is perfect.
- Module 1 activities experience and understanding the scientific content.
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 Keri Marshall at 0207 440 0679 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.