|Location: Buckinghamshire, England||Salary: £52 - £68 per hour|
|Sector: Life Sciences||Type: Contract|
|Contact: Jeremy Farley||Job Published: 30 days ago|
Job Title: Regulatory Affairs Consultant
Rate: £52 - £68 p/h
Term: Initial 12 Months
Key Skills: EMEA, Medical, Pharmaceutical, Drug Development, MRP, CP, Regulatory Affairs, Requirements, EU, SmPC, LOC, CRO, GRL, Commercialization
An experienced Regulatory Affairs Consultant is required to join my client to advise project teams on applicable regulatory issues, project specific issues and issues related to regional regulatory climates. You must have a breadth of regulatory experience in Drug Development & commercialization - therapeutic areas, products, development.
Working from site, this is a truly fantastic opportunity for the right person. If this sounds like an opportunity for you, please read on!
So, what will you be doing as a Regulatory Affairs Consultant?
- Drive the understanding of central & national regulatory requirements
- Develop and ensure effective implantation of regional regulatory strategy and tactics in support of the global development plan
- Provide input for developing & updating the Target EU SmPC
- Maintain & establish strong relationships with Regulatory Agencies
- Act as the Primary contact with EMEA.
- Prepare team, manage, conduct and facilitate meetings with Regulatory agencies.
- Ensure that protocols are developed in alignment with regional registration strategies to support registration and labelling
- Ensure the timely MAA availability
- Responsibility for the submission and acceptance of MAA
What are we looking for in our next Regulatory Affairs Consultant?
- Degree Educated in a Medical or Pharmaceutical discipline
- Possess a breadth of regulatory experience in drug development & commercialization
- Posses strong experience with EU regulatory procedures - CP, MRP
- Experience of working in Project teams
My client is keen to get this position filled ASAP, so if you feel you have the skills, experience and desire to provide exceptional Regulatory Affairs experience, this is the opportunity for you!
If you are interested in joining a well-established, internationally renowned, globally recognised organisation working with experts in their field, hit that apply button now!