Job Reference: 1602-124
Job Duration: 12 months
Start date: a.s.a.p
Description:
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 andprovide support to development projects. Excellent hourly rate of up to £55.00 and the ideal candidate will be able to start immediately! Hands on CTA compilation and submissions experience is essential!
Responsibilities:
*Participate as an activemember 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 ina scientific discipline, with 3-5 years of increasingly responsible regulatory experience in the pharmaceutical industry
*CTA compilation and submission experience - direct authority interaction
*Demonstrated understanding and strategic application of regulations and guidelines for drug development
*Excellent English verbal and written communication skills
*Leadership abilitywithin a team environment
*Ability to work with limited supervision, attention to detail, set priorities to meet timelines andto 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 thisrole or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of yourCV to tbarratt@keypeople.co.uk
Key People is a recruitment consultancy with a reputation for providing good value that's been built up over 20 years.
Clients come to us for three main reasons:
> We achieve results faster
> Our candidates really are a cut above
> We add greater value we think it's because we're a private company driven by clients, not by shareholders.
For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe andalso many around the globe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you'll get the chance to work for some prestigious, blue-chip organisations.
Industry: Pharmaceuticals
Salary: £40 - £55 per hour
Salary Benefits:
Vacancy Type: Contract
Job Skills: CTA, regulatory affairs, global, impd, clinical regulatory, contract, buckinghamshire, clinical trial applications, regulatory affairs consultant, senior, submission manager
Contact Name: Tim Barratt
Website: -
Direct Application URL: -