Contract Reg Consultant - Clinical Strategy - Interim - 6 Months

Recruiter
Talentmark Resourcing Solutions
Location
Reading
Posted
02 Dec 2017
Closes
12 Jan 2018
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
Contract Regulatory Consultant required - Clinical Strategy - Interim - 6 Months

This is an exciting opportunity to work with a global pharmaceutical organisation that is looking to take on board a senior level consultant that can assist, drive and provide solution to their current clinical development projects.

The global pharmaceutical company has a long history of setting themselves apart for the industry and are entering a new phase of change that will impact the long-term success and innovation of the business.

Responsibilities:

- Plan, prepare, and review submissions to regulatory authorities primarily focused on EMA and European submissions but also including FDA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
- Lead regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

Skills Desired:

- Experience in leading, attending and helping a team prepare for a Major Health Authority interactions
- Significant experience of regulatory drug development including product approvals/launches
- Expert knowledge of regulatory affairs
- Broad experience of the pharmaceutical business covering several areas within regulatory affairs - for example, in a global or European marketing company, or a health authority.

Location:UK - Home based flexibility

Rate: Competitive based on experience