Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Regulatory Affairs CMC Team Lead (m/w)

Company: i-Pharm Consulting
Location: Bern
Reference: CRN99700
Closing Date: 24 Nov 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Regulatory Affairs CMC Team Lead (m/w)Office-based in Switzerland / full timeYour responsibilities:- Manage, oversee and develop a team of CMC regulatory professionals.- Accountable for CMC regulatory tasks related to product development, registration and license maintenance for the products handled by the team.- Ensure consistent approaches and development of best practices, as well as the readiness to deputize for the GRA CMC Site Lead when needed. ...

Requirements:

Regulatory Affairs CMC Team Lead (m/w)
Office-based in Switzerland / full time


Your responsibilities:
- Manage, oversee and develop a team of CMC regulatory professionals.
- Accountable for CMC regulatory tasks related to product development, registration and license maintenance for the products handled by the team.
- Ensure consistent approaches and development of best practices, as well as the readiness to deputize for the GRA CMC Site Lead when needed.
- As a Change Control Expert, you are accountable for the timely regulatory assessment of CMC changes, technical changes related to facility and equipment and/or changes in the Global Change Control system in accordance with global regulatory requirements and in close cooperation with GRA Regions.
- You are the first contact point for relevant local technical expert departments regarding regulatory questions related to change control, and may represent GRA in local and global change panels.
- You may represent GRA in local change projects affecting multiple products. In this role you will coordinate and consolidate input from all relevant regulatory functions.
- Acting as SME for facilities and equipment, you are the primary GRA contact point interfacing with relevant technical expert departments for the compilation and maintenance of facility and equipment information for regulatory submissions.
- Representing Global Regulatory Affairs in Core Project Teams for CMC projects as an expert for regulatory questions related to facility and equipment. You are also the primary contact from RA during GMP inspections and for preparation of inspections.
- Coordinate all incoming questions from an inspection within GRA.


Qualifications & Experience:
- University Degree in natural sciences, further education specialized in Regulatory Affairs would be an asset.
- 3-5 years’ experience in biotech or pharmaceutical industry with a minimum of 3 years’ experience in Regulatory Affairs.
- Experience in people management
- Sound knowledge in natural sciences with a focus on biological medicinal products.
- Sound technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, CH, or Australia).
- Fluency German and English required.


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, Manufacturing, R & D, Commercial Operations and Bioinformatics.

www.i-pharmconsulting.com

If you would like to discuss this vacancy further, please call 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 Team Lead (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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.