Do you want to work for a scientifically driven organisation that provides services to accelerate drug, biologics and medical technology development? If you would like the opportunity to work for an organisation that has a huge global footprint, is employee centric providing the best training and has 5% growth within the Regulatory team then this may be the role for you…
We are looking for an customer-centric, driven, passionate individual to join a company who is growing their Regulatory Affairs team globally. The company is looking for a Regulatory Affairs Associate to help support clinical development activities on a local and international level.
This is a permanent position, paying a competitive salary plus excellent benefits. You will be based in the company's site in London.
Reporting to the Regulatory Affairs Manager your role will include:
- Preparation and delivery of regulatory submissions to domestic and international regulatory agencies;
- Perform document quality control checks in accordance with established processes;
- Maintain timelines for components of regulatory deliverables;
- Provide day-to-day department support activities as necessary to aide completion of project deliverables;
- Maintain and train on up-to-date regulatory requirements, guidance and science; and
- May be responsible for other projects and responsibilities as assigned.
Skills and Experience Required:
- Bachelor's Degree in Life Sciences; advanced degree highly preferred (M.D., Pharm.D, Ph.D.);
- Good Regulatory Affairs experience within the Pharmaceutical or CRO industry
- Experience of the EMA Paediatric Investigation Procedure and Investigational Brochure would be beneficial
- Knowledge of EU procedure, ODD and Scientific Advice;
- Experience working directly with domestic regulatory agencies;
- Knowledge of and familiarity with the regulations and practices of EU regulatory agencies;
In addition to a generous basic salary, the company offers the following benefits package:
- Annual holidays
- Private Healthcare
- Additional perks
Full details will be provided upon screening, please note applications will only be accepted from individuals who are eligible to work in the EU and unfortunately sponsorship will not be provided for this role. This is a permanent role based in London and upon successful screening, you will be shortlisted and if interested contacted for an interview. Please note that during the current climate it can take up to two weeks to receive feedback.