Job Reference: J5634230
Updated On: 01/04/2021
Status: Now Interviewing
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Role OverviewWe are currently looking for a Regulatory Affairs Consultant to join a leading Pharmaceutical company based in the South East of the UK, on a 12 month contract. As the Regulatory Affairs Consultant you will be responsible for supporting and executing Regulatory Affairs CMC submissions, as well as developing Regulatory Affairs CMC strategy. This is a fantastic opportunity for an experienced Regulatory Affairs CMC Specialist to join a leading business with strong product pipeline. This role is a 12 month contract and offers home working during the Covid-19 pandemic.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Consultant will be varied however the key duties and responsibilities are as follows:
1. Support on CMC RA Strategy and ensure these are delivered on time and as per project timelines.
2. Execute CMC submissions in liaison with a variety of functions (Most notably the Global RA CMC Lead)
3. The Regulatory Affairs Consultant will be proactive in recognising potential issues throughout product lifecycle, ensuring these are identified are rectified as soon as possible.
4. Contribute towards Regulatory Risk Assessments by identifying possible strengths and weaknesses within the businesses product portfolio.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Consultant we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific or Pharmaceutical Discipline
2. Proven industry experience working as a Regulatory Affairs CMC Specialist or point of contact (Biotechnology/Biologics product experience would be ideal)
3. A working knowledge and practical experience with preparing and executing Regulatory CMC documentation, as part of Marketing Authorisations.
Key Words: Pharmaceutical / Regulatory Affairs / RA / Reg Affairs / Regulatory / CMC / Module 3 / GMP / Biologics / Contract / Contractor / Consultant / RA Consultant / Regulatory Affairs Consultant / Biological / Biotech / Biotechnology
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