(Senior) Regulatory Affairs Associate with French

As a Senior Regulatory Affairs Associate you will have good technical skills and may be developing specialist knowledge of a particular subject and/or market. In this role, you will ensure the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead, you will assure the work of the entire team is delivered on time and that it meets the client’s quality expectations. As a Senior Regulatory Affairs Associate you will have a good understanding the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides.

Key Responsibilities: Preparation & submissions of regulatory files Communicate with Regulatory Operations on the planning of marketing applications and post-approval supplements and variations Coordinate the review and approval of submission-ready documents Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations Qualifications Skills and Experienced required for the role: University degree in a scientific or technical discipline At least 3 years of regulatory affairs experience performing the same activities at global level Thorough understanding of regulatory requirements Excellent project management skills Client-focused approach to work, teamwork and collaboration skills, excellent interpersonal and intercultural communication skills, critical thinking and problem-solving skills Fluent English written and spoken and at least intermediate French language skills