Company: i-Pharm Consulting
Closing Date: 05 Dec 16
Salary (£): Negotiable
CMC Regulatory Affairs Manager (m/f)Office-based in HessenRole / Description:- Responsible for project management team- Managing successful initiation, execution and completion of Regulatory and CMC projects- Main point of contact for clients regarding CMC projects- Regularly interact with clients to understand their requirements- Generate CMC gap analyses based on project development data- Authoring of the Module 2. ...
CMC Regulatory Affairs Manager (m/f)
Office-based in Hessen
Role / Description:
- Responsible for project management team
- Managing successful initiation, execution and completion of Regulatory and CMC projects
- Main point of contact for clients regarding CMC projects
- Regularly interact with clients to understand their requirements
- Generate CMC gap analyses based on project development data
- Authoring of the Module 2.3
- Generation of Module 3
- Preparation of quality variations
- Preparation of the CMC / quality section of IMPDs and INDs
- Preparation of quality sections of scientific advice briefing documents for EMA or National Agency scientific advice procedures
- Management of CMC / quality scientific advice procedures (EMA and National Agencies)
- Degree in pharmacy, biology, biotechnology or equivalent in other Life Sciences
- At least 5 years of experience in CMC-regulatory affairs or other relevant experience in the international pharmaceutical industry or regulatory consultancy
- Experience with:
- Manufacturing process development, scale-up, comparability and validation
- Analytical development and validation
- Strategic input into product development programs
- CMC and regulatory experience with Biosimilars, MAbs, Vaccines or ATMPs
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry inEurope and Germany. We provide both permanent and contract staff to a wide range of
Pharmaceutical, Medical Device, Biotechnology Contract Research Organisations (CROs) and
Contract Manufacturing Organisations (CMO’s). i-Pharm has specific expertise in Clinical Research,Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, drug safety and Bioinformatics.
If you would like to discuss this vacancy further, please call Recruitment Consultant Christian Rommerskirchen on +49 89 71 677 25 41 or email: email@example.com.
If this role is not suitable, Christian is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
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