Senior Regulatory Affairs Associate (MAA)
Parexel International Corporation
Bucharest, București, Romania
We are recruiting for A Senior Regulatory Affairs Associate in Bucharest, Romania. We are looking for experienced candidates who have strong technical skills and ensure the timely performance of work within a project scope to meet quality expectations of the internal regulatory department and the sponsor. It is essential to be self motivating and a leader as when serving as a Project Technical Lead, a Senior Regulatory Affairs Associate assures the work of the entire team is delivered on time and that it meets client’s and Parexel Consulting’s quality expectations.
We are currently looking for a Senior Regulatory Affairs Associate who will have the following responsibilities:
- Medical Writing of Clinical and Non-Clinical Overviews (in CTD format: Modules 2.4 and 2.5) and summaries (2.6 and 2.7) concerning efficacy and safety for the medicine products submitted for marketing authorization;
- Preparation of clinical and nonclinical medical dossier in CTD format (Modules 4 and 5).
- Preparation of Response to deficiency letters, RFI received from Health Authorities.Qualifications• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
• Several years of experience in an industry-related environment preferred
• Experience authoring modules 2.4 - 2.7 or writing in peer reviewed journals. response to deficiency letters, RFI
• Experience with writing clinical summaries (IND, NDA, BLA, MAA), safety reports (DSUR, PSUR) is a plus.
• Ability to summarize regulatory guidelines and apply them appropriately
• Ability to understand and interpret clinical data from different sources
• Critical thinking and problem-solving skills
• Time management
• Proficiency in local language and extensive working knowledge of the English language