Global Regulatory Affairs Manager

Key People


Job ID :

13255


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

regulatory affairs, strategy, RoW, EU, contract, consultant,


Salary :

£60 - £85 per hour


Date Posted :

18 Oct, 2018



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for an experienced Regulatory Consultant, with a strong background in RoW and European strategy. The main focus of this role with be within post approval, but a candidate with development exposure would be preferable.

Responsibilities:

*You will participate a member of a multi-disciplinary team to establish regulatory strategies. Identify and communicate potential risks associated with regulatory strategy scenarios
*Support the preparation, review and submission of regulatory submissions, (i.e.: including marketing applications, clinical trial applications, amendments, variations, responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports).
*Coordinate the preparation and review of responses to Agency questions.
*Manage communication to Health Authorities and internal stakeholders verbally and written
*Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for regulatory submissions
*Provide in-depth reviews of protocols, reports, presentations and documents
*Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support regulatory strategy and submissions
*Provide risk assessments and recommendations for various regulatory scenarios

Experience Required:

*Regulatory experience in the pharmaceutical and/or biotech industry
*Experience with HA and/or EMA regulatory procedures ie: Regulatory Submissions.
*Demonstrated understanding and strategic application of regulations and guidelines for drug development
*Excellent English verbal and written communication skills
*Ability to work within a team environment or individually with limited supervision, attention to detail, set priorities to meet timelines and to motivate and influence others
*Exceptional interpersonal skills with the ability to work with individually or within a multi-disciplinary team with external partners and regulators
*Some international travel may be required
*Bachelors or Masters or advanced degree in a scientific discipline

For further details on this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk.


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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