Regulatory CTA Support Associate
An attractive job opportunity has arisen at a leading multinational pharmaceutical company who is seeking a Regulatory CTA Support Associate to work at their office in Belgium. The company employs 100,000 personnel across 150 countries, working across multiple therapy areas including cardiovascular, oncology and respiratory.
- Ensuring that content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with clients processes and policies.
- Coordinating of CTA lifecycle submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with client policy and procedures.
- Accountable to the Clinical Study Support Team Managerfor overall work plans.
- Accountability for agreed tasks and projects.
- Ensuring independent communication, with a range of internal staff, in support achievement of the assigned goals.
- Ensuring compliance with CTA teams and maintenance process through timely action and completion of records in internal systems.
- Ensuring the quality of own work to agreed timeframes, including compliance with the client's systems and record keeping.
- Implementation of submissions.
Skills and Requirements:
- Scientific or Regulatory Affairs specialist.
- Broad understanding of the Pharmaceutical industry.
- A good understanding of the Clinical Trial Directive and CTA submissions for different regions/countries.
- Ability to lead and build relationships.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in 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 Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.