Drug Regulatory Affairs Manager (German&English)
Posted on Jan 30, 2020 by Harvey Nash IT Recruitment Switzerland
For our client in Rotkreuz we are looking for Drug Regulatory Affairs Manager for 5-month contract.
Job title: Drug Regulatory Affairs Manager
Duration: 03/02/2020 to 30/06/2020
Work location: Rotkreuz
Only English-written CVs will be accepted.
The Job Purpose is to take care of all drug regulatory affairs matters regarding the assigned indication group. Acts as an interface between global Regulatory Affairs departments and Swissmedic in order to obtain new marketing authorizations, support new product launches and ensure regulatory compliance.
- Preparation of the regulatory strategy for new submissions
- Timely submission of new products to Swissmedic 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
- 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
Education: Pharmacist or natural scientist preferably with medical background
Languages: German (fluent), English (intermediate to advanced) and French (desirable)
Experience: Intermediate (1-2 years Regulatory experience)
Regulatory Competencies: Organisation of new submissions and product maintenance in due time. 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. Visionary and future-oriented mindset, continuously challenging the status quo to achieve overall business targets. Lives passion for the 3 C's: consumer, customer, competition.
Customer relations: Understanding of market structures and business impact of actions. Strategic business partner to Business Development, Quality Assurance and Supply Chain.
Personal Profile: Emphatic, powerful, courageous and visionary. A strong team player who gets to the front, shows flexibility in a changing environment and always fights for excellent results.
For further details please contact: