Company: i-Pharm Consulting
Closing Date: 03 Apr 17
Salary (£): 60,000 - 80,000
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 ...
Regulatory Affairs Managers – CMC (m/w)
Office-based in Hessen
- 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
- 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
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.
If you would like to discuss this vacancy further, please call Recruitment Consultant Christian Rommerskirchen on +49 89 71 677 25 41 or email: firstname.lastname@example.org.
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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