Drug Regulatory Affairs Manager
A leading Swiss pharmaceutical company are currently looking to hire a Drug Regulatory Affairs Manager to be based at their site in Switzerland. The company employ over 100,000 professionals and have operations in more than 140 countries worldwide.
- Prepare the regulatory strategy for new submissions.
- Submit new products in agreement with the yearly target.
- Obtain a number of marketing authorizations in accordance with the yearly target.
- Drive product maintenance to ensure regulatory compliance.
- Provide close regulatory support to the product launch work stream.
- Act as a strategic business partner to Business Development, Quality Assurance, Supply Chain as well as for other Global Regulatory Groups (RCCs).
- Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future requirements on time always work in accordance with Good Regulatory Practice.
- Strategic business partner to Business Development, Quality Assurance and Supply Chain.
- Organisation of new submissions and product maintenance in due time.
Skills and Requirements:
- Pharmacist or natural scientist preferably with medical background.
- 1-2 years Regulatory experience.
- Fluency in German and proficiency in English, with French desirable.
- Experience and know-how in Drug Regulatory Affairs and project management.
- Knowledge of Swiss regulations and guidelines.
- Know how on Quality Assurance and Pharmaceutical Technology.
- Understanding of market structures and business impact of actions.
- 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 Manon Luflade at +44 2038540586 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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