Regulatory Affairs Manager
Responded to 90% of applications in the past 30 days, typically in 3 days
Middle (2-5 years), Senior (5-10 years)
English - advanced
Hiring candidates willing to relocate
B. Braun is a major international company and a leading provider of the global health care market. More than 900 employees develop, produce and sell high-quality products for worldwide use.
Your main tasks:
- Apply regulations to business practices and provide regulatory input, information and guidance to the organization (all divisions);
- Maintain the relationships with the Regulatory, Government and Certification Authorities/bodies;
- Develop and implement regulatory & submission strategies;
- Assure adequate prioritization, scheduling, preparation, and dispatch of regulatory submissions according to Global Regulatory Affairs strategy plans;
- Perform the registration documentation in accordance with regulatory guidelines and internal processes within timelines;
- Coordinate and adapt the authorization, renewal, completion and variation dossiers for all drug products;
- Ensure consistent and sustainable interpretation of company standards and regulatory compliance;
- Act as a liaison with Global Regulatory Affairs department of the Headquarter, B. Braun Melsungen AG to facilitate effective management of submissions;
- Coordinate Local Regulatory Affairs team.
- University degree (pharmacy, chemistry, Biochemistry, Biology);
- Minimum 5 years of experience in pharmaceutical industry, medical field, or as a biochemist or chimist;
- Minimum of 2 years experience in regulatory affairs (pharma, medical devices, biocides).
- Very good English skills;
- Good knowledge of MS Office package software
- Demonstrate a positive attitude and think in terms of solutions
- Analytical and structured way of thinking and working;
- Organized with good communication skills;
- Willing to travel internationally.
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary and benefits, all within a dynamic family-owned company.