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Job Details

Regulatory CTA Submissions Manager, 12 month contract

Company: Key People Limited
Location: High Wycombe
Reference: 1606-28
Closing Date: 08 Dec 16
Type: Contract
Salary (£): 80,000 - 100,000
Benefits:

Job Summary:

My client is currently seeking a Regulatory Affairs CTA Submissions Manager to join their team on a 12 month contract basis. This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas.

Requirements:

My client is currently seeking a Regulatory Affairs CTA Submissions Manager to join their team on a 12 month contract basis. This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas.

The ideal person will have experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
Successful candidates for this position have: in depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.
Responsibilities:
• 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 (e.g., Health Authority responses, amendments, etc.).
• Submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country.
• Responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
• Initiate the Drug Release 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.

WORKING RELATIONSHIPS/INTERFACES:
• Regulatory Affairs staff within the global, regional, and therapeutic area organizations
• Cross-functional CTA working group team members
• Local clinical trials staff
• Health Authorities
• CROs (if applicable)

Experience Required:
• Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required
• 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.
• Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
• Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency).
• Ability to lead complex projects and a high degree of problem solving capability required. Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills.
• Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization. Must be able to work independently, strong initiative. May have to work remotely from supervisor.

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

Apply for this job: Regulatory CTA Submissions Manager, 12 month 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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