BE - QC - Clinical Trial Regulatory Leader - Normal
An internationally renowned pharmaceutical company is currently advertising a vacancy for a Clinical Trial Regulatory Leader - Normal in their office in Belgium. This top 10 pharma company works across multiple sectors, including medical devices, pharmaceutical research, and consumer health. The vacancy offers an exciting opportunity to work with a company with over 100,000 professionals around the globe.
- 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.).
- Submit the CTAs directly to Health Authorities or facilitate the CTA submission by local personnel in each country.
- Interact with Health Authorities and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
- Manage the Output Protection Process for assigned trials and ensure that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system.
- Liaise with, and oversee, CRO staff, as required.
- Identify and proactively respond to issues, problems, or opportunities as it relates to the leading the CTA workgroup.
- Independently identify the need for and collect information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities.
- Integrate information from a variety of sources, detect trends, associations, and cause-effect relationships, and communicate to supervisor, CTA working group, and others as appropriate.
- Propose relevant options for addressing problems or opportunities to supervisor.
- Make decisions independently for day-to-day activities of CTA workgroup that relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process Owner.
- Form relations with:
- Regulatory Affairs staff within the global, regional, and therapeutic area organisations
- Cross-functional CTA working group team members
- Local clinical trials staff
- Health Authorities
- CROs (if applicable)
Skills and 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 of 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).
- May have to work remotely from supervisor.
- Good interpersonal skills, including presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Anna Bigiotti at +44 2038542470 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.