Regulatory Affairs Associate - CTA
Proclinical are recruiting for a Regulatory Affairs Associate - CTA to join a pharmaceutical organisation. This role is on a contract basis and is located in either Uxbridge or Cambridge.
- Partake in the process improvements and/or any other special projects in regulatory affairs connected to clinical trials.
- Conduct document archiving and retrieval functions rendering to divisional SOPs.
- Assist with inspection promptness actions when suitable.
- Guarantee own work complies with formed practices, policies, procedures and any other regulatory or any other needs.
- Contribute to and when required, offer aid to the company's regulatory clinical trial user group to share best practice and CTA linked conversations.
- Support in expediting and improving regulatory CTA administrative actions by coaching and advising new or less experienced personnel.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Familiarity in administrative asks within a corporate or linked business work setting, preferably in the healthcare sector.
- Rior involvement in a regulator CTA role assisting with medicinal products.
- Acquaintance with authoring or updating procedures would be ideal.
- Capable of being a fast learner with the ability to be a flexible and adaptable individual when it comes to change, moving between projects easily and offer aid/knowledge when required.
- Expertise on regulatory CTA needs and the role of regulatory affairs as these pertain to medicinal product clinical trials, which involves knowledge and comprehension of ICH standards and varying regional needs in the allocated markets.
- An organised individual with a high attention to detail.
- Computer literacy.
- Project management capabilities with the capacity to handle various tasks concurrently without compromise to timelines or quality.
- Communication skills both verbally and in writing as well as clear and concise.
- Works well with others in a team within a highly matrixed setting.
- Able to implement various tasks as designated.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on email@example.com
Proclinical 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.