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Job Details

Senior Regulatory CTA Submissions Manager

Company: Key People Limited
Location: Buckinghamshire
Reference: BBBH22477
Closing Date: 24 Aug 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

A leading pharmaceutical company currently seeks a Senior Regulatory Consultant to join their team on an initial 6 month contract basis. Within this role you will be responsible for managing regulatory Clinical Trial Applications (CTA) submission activities (Phase 1 - 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).

Requirements:

A leading pharmaceutical company currently seeks a Senior Regulatory Consultant to join their team on an initial 6 month contract basis. Within this role you will be responsible for managing regulatory Clinical Trial Applications (CTA) submission activities (Phase 1 - 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).

To be successful within this role, you must have experience in regulatory CTA submissions, knowledge of CTA requirements and have previously been responsible for the execution of the global CTA submission strategy and have knowledge of CTAs throughout the lifecycle of the trial. In depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills are essential.

Responsibilities:
- The Regulatory Clinical Trial Application submission manager will ensure that the required regulatory intelligence is in place to comply with country specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions.
- The CTA submission manager will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
- The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- The CTA submission manager manages the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
- If Clinical Research Organizations are contracted to handle some (or all) aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staff, as required.

Experience Required:
- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology.
- Ideal candidate would possess a minimum of 4 - 6 years experience within regulatory affairs in the pharmaceutical industry.
- An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.

For further details, please contact Tim Barratt as soon as possible.

Apply for this job: Senior Regulatory CTA Submissions Manager

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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