Manager / Sr. Manager Regulatory Affairs CMC Biologics (m/f/d) | Munich | Pharma
In this role you will provide European regulatory CMC guidance and strategy for assigned products and represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working teams, regulatory interactions in scientific opinions, CMOs). The role creates or leads the creation of regulatory CMC documents during development and life-cycle management as IMPDs and MAAs in a way that is scientifically sound, commercially viable and in line with regulatory CMC standards.
If you are keen to experience this at a global research-based pharmaceutical company, then you have come to the right place!
What will your activities as "Manager / Sr. Manager RACMC Biologics (m/f/d)" involve?
- Development of regulatory strategies including risk assessments and change control processes
- Provide essential input to drug development, manufacturing, and commercialization through advanced regulatory EU expertise
- Lead the preparation of CMC documentation (IMPDs, Module 2.3 & 3) and subsequent review
- Ensure regulatory compliance (EU focus)
- Close cooperation with CMC Regulatory Affairs and technical experts across the group
- Represent RA CMC function in global and local project team meetings
- Represent the EU RACMC function in global RACMC and CMC development teams and provide CMC regulatory guidance and strategies
- Review CMC documents, develop regulatory strategies, provide risk assessments
- Lead the preparation and conduct of health authority meetings.
- Interpret, develop strategies and prepare responses to health authority requests for information.
- Work closely with global RACMC colleagues and technical experts in all regions.
What does the position as "Manager / Sr. Manager RACMC Biologics (m/f/d)" offer you?
- Type of contract: unlimited
- Holiday: 30 days / year
- Working hours: 40 hours / week
- Benefits: Opportunities for further qualification, a pleasant working atmosphere in a committed team, flat hierarchies and short decision-making processes, various in-house and external catering options, childcare options in the immediate vicinity, wide range of health and sports activities (e.g. company doctor); highly flexible working model; attractive remuneration and benefits package
- Accessibility: On-site parking and excellent public transport connections
- Start date: As soon as possible
- A hybrid work model or remote employment can be discussed!
What requirements should you have as "Manager / Sr. Manager RACMC Biologics (m/f/d)"?
- Completed scientific/pharmaceutical studies (pharmacy, chemistry, biology or similar)
- 5 years of experience in the pharmaceutical industry
- 1-2 years hands-on experience in RACMC Biologics (CMO Biologics or Pharma)
- Extensive pharmaceutical knowledge of different dosage forms, their production and analytical testing
- Very good communication skills in dealing with interdisciplinary multicultural teams
- Very good written & spoken English; other language skills are a plus
- Good knowledge of data processing
Information about our client:
The company is one of the 20 largest pharmaceutical companies in the world and operates in 12 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thrombotic diseases and in the field of oncology.
Does this position appeal to you? Then you should apply right away! If you would like to receive further or alternative positions, I would also be pleased to receive your application!
I look forward to receiving your application!