Hobson Prior are looking for a Senior Regulatory Affairs Associate to join a leading healthcare organisation on a contract basis in High Wycombe. This position will be responsible for managing regulatory Clinical Trial Applications submission activities for assigned clinical trials (Phase 1 - Phase 4 mainly in the Pulmonary Hypertension therapeutic area).

Job Responsibilities:

• 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.).
• Accountable to either 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.
• 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.

Key Skills:

• 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.
• Excellent command of English, spoken and written is required.

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.

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.