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Job Details

Regulatory Affairs CMC Manager (m/w)

Company: i-Pharm Consulting
Location: Hessen
Reference: CRN221
Closing Date: 05 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

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. ...

Requirements:

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)


Requirements:
- 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


To Apply:

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.

www.i-pharmconsulting.com

If you would like to discuss this vacancy further, please call Recruitment Consultant Christian Rommerskirchen on +49 89 71 677 25 41 or email: crommerskirchen@i-pharmconsulting.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.

Apply for this job: Regulatory Affairs CMC Manager (m/w)

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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