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Job Details

Regulatory Affairs Manager (CTA submissions) contract

Company: Key People Limited
Location: England
Reference: 1603-57
Closing Date: 08 Dec 16
Type: Contract
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

A 12 month contract has become available with a leading Pharmaceutical company based in Buckinghamshire. Within this role you will manage the submission of Global CTAs and provide support to development projects. Excellent hourly rate of up to £44.00 and the ideal candidate will be able to start immediately!

Requirements:

A 12 month contract has become available with a leading Pharmaceutical company based in Buckinghamshire. Within this role you will manage the submission of Global CTAs and provide support to development projects. Excellent hourly rate of up to £44.00 and the ideal candidate will be able to start immediately!

Responsibilities:

• Participate as an active member of a multi-disciplinary clinical team to establish regulatory strategies for the clinical trial applications for the development programs. Identify and communicate potential risks associated with strategy scenarios
• Manage the regulatory activities with the CROs and ensure quality regulatory submissions
• Provide in-depth reviews of protocols, reports, presentations and documents
• Coordinate preparation and review of clinical trial applications, amendments and responses to Agency questions.
• Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
• Manage timelines to ensure approvals are timely and development objectives are met
• Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
• Provide risk assessments and recommendations for various regulatory scenarios
• Participate in the electronic review and quality verification of regulatory submissions

Minimum Requirements:

• Bachelors or Masters or advanced degree in a scientific discipline, with 3-5 years of increasingly responsible regulatory experience in the pharmaceutical industry
• Demonstrated understanding and strategic application of regulations and guidelines for drug development
• Excellent English verbal and written communication skills
• Leadership ability within a team environment
• Ability to work 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 individually, within a multi-disciplinary team, as well as with external partners and regulators
• Some travel may be required

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Apply for this job: Regulatory Affairs Manager (CTA submissions) contract

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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