Manager Regulatory Affairs (m/w/d)
Location
Augsburg | Germany
Job description
- Evaluate regulatory requirements and provide regulatory strategies when preparing or managing the timely delivery of high quality documentation required for initial marketing authorization applications and dossier updates worldwide
- Identify potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations
- Provide input and collaborate with partners about implementing strategies, ensuring timelines and requirements, or assuring congruency and compliance
- Take over the regulatory lead for defined project tasks.
- Act as representative of regulatory functions in cross-functional project teams and workstreams
- Own the preparation of responses to regulatory relevant queries from various partners and directly interact with regulatory authorities and/or with regulatory functions in the countries
- University degree in natural sciences, ideally PhD, or comparable qualification
- Minimum of two years of work experience in pharmaceutical or biotech regulatory affairs
- Proficient in English (oral and written)
- Strong communication, negotiation, and interpersonal skills
- Ability to work in interdisciplinary teams
- Ability to work in a matrix environment
- Ability to interpret scientific data and to construct persuasive regulatory documents
- Exciting, self-organized and responsible tasks
- Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
- Flexi time agreement, flexible working time model, work-life balance
- Opportunities for specialization and subject-specific further education and training
- Extremely collegial team with a friendly approach
- Various development opportunities within the Teccon Group
The Role is for 32h/week.
The gross annual fulltime salary is at least EUR 60.000€ but of course we offer overpayment in line with the market, depending on qualifications and professional experience.
#J-18808-Ljbffr
Job tags
Salary
