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Job Details

Regulatory CTA Applications Manager

Company: MSI Group Limited
Location:
Reference: VR-8368
Closing Date: 31 Aug 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

6 Month Contract - Berkshire

Requirements:

Our Client, a globally recognised pharmaceutical company are actively searching for a professional to join their team in the UK as Regulatory Clinical Trial Applications (CTA) Manager. The successful individual will be responsible for managing Regulatory CTA submission activities for assigned clinical trials.

Key Responsibilities:

  • Clinical Trial Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
  • The Regulatory Clinical Trial Application submission manager has 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
  • 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 (CTA Working Group [WG]) that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
  • 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.

Skills/Education Requirements:

  • 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.
  • 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.

 

Apply for this job: Regulatory CTA Applications Manager

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
SE1 1QL
England
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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