Regulatory Affairs Consultant

Parexel, a leading clinical research organization, is expanding its Regulatory team in Canada and we are seeking a highly experienced professional to join our talented team. This exciting opportunity calls for an individual with extensive expertise in managing global regulatory strategies and leading a team of local experts. The ideal candidate should possess a passion for regulatory clinical trials and excel in client interactions.

The role requires a minimum of six years of experience in the Clinical Trial Regulatory Area, with a proven track record as a global regulatory affairs lead. The successful candidate will be responsible for coordinating the compilation of Core dossiers for submission by Subject Matter Experts to various countries worldwide, overseeing the entire process from start to finish. A thorough understanding of EU-CTR 536/2014 is preferred, but individuals with a depth of CTA submission experience will be considered. Additionally, the ability to manage information flow, track project progress, and resolve issues in a collaborative team environment are crucial to be successful as a Regulatory Affairs Consultant.

Key responsibilities include reviewing critical technical documents such as clinical trial protocols, reports, and study drug labels to ensure regulatory compliance and consistency across all materials. The role also involves interfacing with project teams and regulatory authorities on technical matters and supporting sponsors in developing optimized clinical trial submission strategies. Strong project management skills are crucial for success in this position.

The ideal candidate should possess advanced English language skills, both written and spoken, and demonstrate a client-focused approach to work. Results orientation, teamwork, and collaboration skills are vital, as are consulting abilities and excellent interpersonal and intercultural communication skills. Critical thinking, problem-solving capabilities, and proficiency in the local language are also essential attributes for this role.

This opportunity at Parexel offers a chance to work with a highly skilled team in a dynamic and growing field, making a significant impact on the regulatory aspects of clinical trials on a global scale.

Due to the nature of the Consultant's projects, candidates in the Eastern Time Zone of Canada are highly preferred.