Regulatory Affairs Manager CMC (m/f/x) | Baden- Württemberg | Pharma
Our client, a gastroenterology company, provides patients, physicians and partners with affected inflammatory diseases and metabolic problems. In 65 countries, the preparations are near to those involved and the company is committed to further global presence and availability of the products based on continuity.
What will your tasks as Regulatory Affairs Manager CMC be?
- Production and updating of the pharmaceutical documentation (Module 3, QOS) for the supported products in e-CTD format.
- Support in the development and implementation of regulatory strategies as well as the coordination of regulatory processes and projects
- Preparation of submissions and support of new marketing authorisation procedures in cooperation with international partners
- Assessment of change projects (change control procedures) and follow-up of regulatory implementation
- Bachelor/master's in pharmacy, chemistry, biochemistry, biotechnology
- At least 3 years of experience in CMC
- depth experience of regulatory and medicinal product law environment, both nationally and internationally
- Experience with submission management systems (docuBridge)
Essential knowledge & skills:
- Excellent written and communication skills in English and German
- Demonstrated teamwork and working in a multidisciplinary matrix setting
What does the position of Regulatory Affairs Manager CMC offer you?
- Salary: base salary depending on individual experience
- Type of contract: unlimited
- Holiday: 30 days / year
- Working hours: 40 hours / week
- Benefits: International and growing family business with short decision-making processes, new work, flexible working hours and mobile working
- Access: Very good public transport connections
- Home office: currently 2-3 days/week possible
- Start date: At the next available date
My contact details:
- Email: email@example.com
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
I look forward to your application!