Hobson Prior are looking for a Senior Regulatory Clinical Trial Application Submission Manager to join a leading global pharmaceutical and biotechnology company who specialise in products and late-stage development compounds targeting several different diseases.

Job Responsibilities:

• Responsible for managing regulatory Clinical Trial Applications submission activities for allocated clinical trials.
• Accountable for the implementation of the global CTA submission strategy, as well as the quality and extensiveness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
• Ensure that the mandatory regulatory requirements are in place to comply with country-specific requirements
• Lead a cross-functional team that will accumulate, publish and produce Clinical Trial Authorization Applications and associated lifecycle submissions.
• In charge of interactions with Health Authorities and primary point of contact for any submissions of CTAs.

Key Skills:

• Detailed regulatory submission experience and regulatory knowledge
• Proven project management experience and leadership skills
• Excellent knowledge of English, spoken and written
• High level of Self-awareness and Flexibility
• Verified ability to lead multi-functional teams, building strong and productive relationships across an organization.

Requirements:

• Bachelor's degree or equivalent in scientific field or related experience with pharmaceutical or health sciences industry is essential
• Minimum of 4-6 years' experience within regulatory affairs in the pharmaceutical industry is desirable
• Prior knowledge of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is advantageous

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.