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Job Details

Regulatory Affairs Manager CMC (m/f)

Company: i-Pharm Consulting
Location: Hessen
Reference: CRN7899
Closing Date: 03 Apr 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

Regulatory Affairs Managers – CMC (m/w)Office-based in HessenJob Description:- Compose high quality, global CMC clinical (IND/CTA) and marketing applications (NDA/MAA), including authorship in some sections- Lead communications with global regulatory agencies (FDA, EMA, and others) and facilitate review and approval of submissions- Interact with management from multiple internal functional areas, corporate partners, international regulators and external experts- Lead and/or participate in cr ...

Requirements:

Regulatory Affairs Managers – CMC (m/w)
Office-based in Hessen


Job Description:

- Compose high quality, global CMC clinical (IND/CTA) and marketing applications (NDA/MAA), including authorship in some sections
- Lead communications with global regulatory agencies (FDA, EMA, and others) and facilitate review and approval of submissions
- Interact with management from multiple internal functional areas, corporate partners, international regulators and external experts
- Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities
- Support the leadership team to drive development of innovative regulatory policy


Requirements:

- Advanced science degree (Master or PhD) or equivalent in biology, biochemistry, pharmacy or relevant engineering discipline
- 3 to 10 years of experience in Biotech CMC Regulatory or in pharmaceutical development activities combined with a strong understanding of regulatory affairs
- Good project leadership skills and experience, including working cross–functionally and crossdisciplines
- Good leadership skills with a focus on ability to influence in a changing environment and to work under pressure
- Strong prioritization skills, happy to work both collaboratively and independently, track record in effective problem solving
- Outstanding interpersonal skills, in English; German is an advantage; direct experiences with working across cultural areas in a global environment is a plus

To Apply:

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in Europe and Germany. We provide both permanent and contract staff to a wide range of
Pharmaceutical, Medical Device, Biotechnology Contract Research Organizations (CROs) and
Contract Manufacturing Organizations (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 Manager CMC (m/f)

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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