for our client a - leading pharmaceutical company - we are contracting a:
Drug Regulatory Affairs Coordinator
- Taking care of all drug regulatory affairs matters regarding the assigned indication group.
- Acting 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
- 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
- Pharmacist or natural scientist preferably with medical background
- German (fluent), English (intermediate to advanced) and French (desirable)
- Intermediate (1-2 years Regulatory experience)
- 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.
- Understanding of market structures and business impact of actions.
- Strategic business partner to Business Development, Quality Assurance and Supply Chain.
- 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.
This multifaceted project provides the opportunity to apply and increase your expert knowledge in one of the largest pharmaceutical companies worldwide. To submit your complete CV including diplomas and references just use the button ‘Apply'. We are looking forward receiving your application today!