Regulatory Affairs Manager

  • Job Reference: RA0001
  • Date Posted: 23 April 2015
  • Recruiter: Pharma.Direct UK & Europe Ltd
  • Location: London
  • Salary: On Application
  • Bonus/Benefits: N/A
  • Sector: Regulatory Affairs, Quality Assurance, Pharmaceutical
  • Job Type: Contract
  • Duration: 6 months
  • Work Hours: Full Time
  • Contact: Simon Thomas
  • Email: simon@pharmadirect.org.uk
  • Telephone: 01234 216 300

Job Description

Pharma.Direct UK & Europe Ltd is looking for an experienced Regulatory Affairs Manager, CMC for a Freelance Contract assignment based in the South East, UK;

• Regulatory Affairs Manager, CMC
• South East, UK
• Contract 
• Negotiable 
• Full time onsite

Responsibilities: 
• Support Global and regional teams; work flexibly within and across regions to meet business objectives.
• New Compound Development
• CMC activities for pharmaceutical products development/licensing
• Global product, new product applications and maintenance (CMC variations, answer Regulator questions, renewals etc)
• Regulatory CMC guidance to cross functional teams
• Change control and follow up

Requirements 
Degree in Science or related discipline
Strong EMEA Regulatory Affairs experience
Regulatory Affairs, EMEA submissions, renewal and variations, change control process
Drug dossiers, CMC, knowledge of GMP

Please call Simon on +44 (0)1234 216 300 or email your CV to simon@pharmadirect.org.uk