Top 10 Pharmaceutical client are looking for a Regulatory Clinical Trial Application Submission manager to join their team – remotely initially but eventually to be on-site in Buckinghamshire.

You will be responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).

As a Regulatory Clinical Trial Application submission manager you 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.

The Successful candidate for this position will have in depth regulatory submission experience and    regulatory knowledge, project management and leadership skills and strong communication skills.

Principal responsibilities for Regulatory Clinical Trial submission manager Position, include:

• 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 (e.g., Health Authority responses, amendments, etc.).
• 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 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. 

Knowledge / education / 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.
• Strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur.
• 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.
•  High level of Self-Awareness and Adaptability and strong impact and influencing skills.
• Demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organization.
• Able to work independently, strong initiative. May have to work remotely from supervisor.

If you available at short notice and able to take up a contract role initially until the end of 2020 but likely to be extended into 2021, please call me or email Glen Fairbrother / glenf@msipharma.com / 020279401212