Bayer is recruiting: Regulatory CMC Manager
Bayer is currently looking for candidates to fill the permanent position as Regulatory CMC Manager. This is an entry position and one of the rare opportunities at the moment, which are advertised externally. So take your chance and submit your application!
Details on the job posting are available below or here via the webpage.
Regulatory CMC Manager (m/f/d)
Your tasks and responsibilities
- Responsible for strategic and operational support of manufacturing transfer projects in cooperation with the supervisor
- Responsible for creation and implementation of a regulatory CMC strategy with regard to assigned projects in cooperation with the supervisor and other relevant functions
- Early identification of major regulatory hurdles and issues with regard to CMC related topics, regulatory guidelines and legal requirements, as well as coordination of respective corrective actions
- Responsible for timely availability and final content of CMC sections for variation submission to health authorities incl. tracking of CMC changes and processing requests for related documentation
- Coordination of responses to health authority requests and implementation of CMC changes after health authority approvals to ensure regulatory CMC compliance
- Prepare proposals and support implementation of standards concerning CMC documentation
Who you are
- University degree in natural or medical science, ideally with a PhD
- Experience within the pharmaceutical industry, preferably within development- or quality assurance functions
- Knowledge of medicinal product registration is an advantage
- Scientific and technical expertise including the ability to develop robust regulatory timelines and action plans
- Ideally knowledge of drug development as well as country specific regulations and guidance documents and license variations
- Good analytical skills and experience in project management and ability to build partnerships in a global environment and work collaboratively with others to meet shared objectives
- Being open-minded, goal oriented and having good communication skills
- Fluency in English, both verbal and written; very good knowledge in another language (preferably German)
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Country: Germany
Location: Wuppertal-Aprath
Reference Code: 36326
Functional Area: Regulatory Affairs
Entry Level: Professional (m/f)