Experienced RA Associate
- To reinforce our Clinical Development Business unit, RA department, we are looking for an Experienced Regulatory Affairs Associate;
- The Regulatory Affairs Associate (RAA) is responsible for reviewing the compliance of the regulatory documents required by the different EU authorities; she/he is responsible for managing and submitting the clinical application dossiers to the authorities in support of new product development activities. The RAA should report to a RA Manager.
- Respond to routine regulatory queries for information and documents;
- Stay at the forefront of evolving regulatory requirements and be proactive in maintaining compliance;
- Prepare, review and submit regulatory clinical trial application and notifications;
- Compilation of electronic reports using available electronic publishing tools;
- Communication with authorities;
- Respect of quality commitments;
- Participating in the continual improvement of the Quality System.
Required skills and qualities and expected level:
- At least 2 years’ experience in a similar position with CTA activities;
- Perfect knowledge of the regulatory requirements and legislation of EU authorities;
- Knowledge of CTA European format;
- Knowledge in the use of document management and publishing tools;
- Excellent knowledge of GCP, GMP and ICH guidelines;
- Computer proficiency and adaptability working with a variety of databases, word processing, etc.;
- Concern for quality and compliance; integrity and consistency;
- Strong organizational skills;
- Ability to work in a team environment with shifting priorities and requirements;
- Good communicator;
- Excellent English level both written and verbal.
Required level of education:
- Ph.D. or Master’s degree in scientific discipline or four years related experience or equivalent combination.
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