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 Manager (CMC) - Biotech

Company: Barrington James Clinical
Location:
Reference: CRBG - RACMCB
Closing Date: 08 Feb 19
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

Boisimilars development

Requirements:

Your tasks:

  • Planning and preparation of documents for the approval of biotechnology drugs in USA and Europe with focus on CMC (eg Briefing Books, IND / IMPD, CTD Module 3, answering questions from the regulatory authorities)
  • Coordination and execution of regulatory activities for our development programs with the departments involved (development, quality control and quality management) and in cooperation with our licensing partners
  • Participation in project teams and contacts to external partners and contract manufacturers in regulatory issues
  • Control, processing and approval of the documentation of contract manufacturers as well as internal development reports
  • Development and implementation of regulatory strategies and support for tech transfers of biotechnological active substances
  • Regulatory compliance checks and evaluation of changes
  • Ensuring compliance with relevant regulations and regulations

Your qualification:

  • Natural science degree, preferably biology, biotechnology, pharmacy or chemistry or related field
  • several years of experience in drug approval in the US and Europe
  • Practical experience in creating CMC Drug Substance documents for BLA / MAA submissions
  • Sound knowledge of the requirements for the development and production of biotechnological active ingredients
  • Preferably experience with tech transfer projects
  • Ideally, knowledge of the EMA / FDA guidelines and requirements for the development of biosimilars
  • Enthusiasm and creativity for the design of a biopharmaceutical company
  • Safe German and very good English language skills
  • Independent, careful, structured way of working
  • teamwork

Apply for this job: Regulatory Affairs Manager (CMC) - Biotech

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
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.