job details for:
Regulatory Affairs - Regulatory Affairs Consultant Jobs - Buckinghamshire

Regulatory Affairs - Regulatory Affairs Consultant Jobs - Buckinghamshire (Job Ref: WR/JOBS/29737-16239)

Job Description :

Flame Pharma Regulatory Affairs Jobs - Regulatory Affairs Consultant Job - Buckinghamshire

Excellent package

Flame Pharma is working with a leading regulatory affairs consultancy in recruiting a Regulatory Consultant.  This full time, permanent opportunity will be varied and flexible as projects are undertaken for many different clients on a wide range of product types and therapeutic areas.  Projects are undertaken on a project team basis and the successful candidate can expect to act as project leader for projects fitting his or her particular skills and also to participate as a discipline specialist in other Consultants’ teams.

The Role

• Advising on regulatory strategy and planning R&D programmes.
• Regulatory desk research to identify current regulatory requirements.
• Assessment of scientific data.
• Preparation of regulatory submissions (e.g. clinical trial applications, marketing authorisations, orphan drugs).
• Represent clients and manage procedures with regulatory authorities (e.g. scientific advice).
• Writing overviews and summaries.
• Appeals and hearings.
• Searches for products for in-licensing

The Person

• The ideal candidate will have substantial experience in regulatory affairs
• Candidates should present a proactive, customer-orientated style and have the flair and enthusiasm to identify and develop new business opportunities within their client-base.
• Excellent written and verbal communication skills are essential and candidates should demonstrate that they have the ability to interact with a broad range of clients at all levels of seniority.
• The ideal candidate will have had practical experience in an R&D discipline before moving to regulatory affairs.
• Experience working in pharmaceutical companies, CROs or regulatory authorities will be considered relevant.

For more information please apply for this position or alternatively call Flame Pharma on 0800 0850858

Key Words

Regulatory Affairs, Regulatory Affairs Consultant, Regulatory Affairs Consultancy, Buckinghamshire,