Regulatory Affairs Manager (m/w/d) - Global Life-Cycle-Management | Stuttgart area | Pharma
You are an expert for regulatory activities for marketing authorizations in a global environment? Publishing according to eCTD / eSubmission standards is one of your key competencies? You want to play in active part in setting up regulatory strategy? If you are interested in experiencing this at a very well-positioned medium-sized and internationally operating pharmaceutical company, then you have come to the right place!
What will your activities as "Regulatory Affairs Manager (m/f/x)" involve?
- Independent planning, preparation and implementation of regulatory activities for granted marketing authorizations worldwide
- Definition of regulatory and pharmaceutical requirements for submissions in close cooperation with local regulatory colleagues & consultants
- Creation, maintenance and compilation of regulatory documents for registrations, renewals and notifications of changes
- Publishing according to eCTD / eSubmission standards
- Coordination and preparation of timely responses to questions from authorities
- Maintenance and updating of regulatory data and databases in accordance with legal requirements and internal standards
- Close cooperation and communication with other departments, consultants, CMOs and country offices, including pro-active advice on potential regulatory risks and recommendation of compliant measures
- Monitoring, interpretation and implementation of regulatory developments and communication of relevant changes to internal stakeholders
- Active participation with regard to important departmental goals such as strategy development, compliance activities, improvement of intra- & interdisciplinary cooperation, optimization of internal processes & standards
What does the position as "Regulatory Affairs Manager (m/f/x)" offer you?
- Salary: base salary + 13th salary
- Contract type: unlimited
- Vacation: 30 days / year
- Working time: 40 hours / week
- Accessibility: Very good transport connections by public transport; sufficient parking spaces available
- Start date: At the next possible date
- Homeoffice: 2 days / week or up to 8 days in a row (40% remote)
What requirements should you bring as "Regulatory Affairs Manager (m/f/x)"?
- Completed studies in pharmacy, (veterinary) medicine or comparable natural sciences
- Master of Drug Regulatory Affairs is an advantage
- 3+ years of professional experience in regulatory affairs in the pharmaceutical industry
- Extensive knowledge of technical & regulatory requirements of medicinal products and experience with registration & life cycle management activities
- Experience in negotiation / communication with regulatory authorities
- Experience in handling and maintaining Regulatory Information Management Systems & Databases
- Extensive knowledge of project management
- Reliability, team spirit, initiative, cross-departmental thinking and the ability to manage several projects simultaneously
- Very good written and spoken English; knowledge of German and other languages is an advantage
Information about our customer:
Our client is an international pharmaceutical company with about 1000 employees in more than 30 countries. The company has been completely family-owned from the very beginning (founded in 1971) and develops and sells biofactor and generic products. The product range includes prescription drugs as well as OTC products and dietary supplements. As part of a large-scale growth initiative, the company plans to multiply its turnover in the coming years.
Does this position appeal to you? Then you should apply now! If you would like to receive further or alternative positions, I would also be pleased to receive your application!
I look forward to your application!