Global Regulatory Expert

6 days ago


Ottawa, Ontario, Canada Alimentiv Inc Full time
Overview

We are a dynamic and innovative company dedicated to advancing the field of clinical research. Our regulatory affairs team plays a critical role in ensuring compliance with regulatory requirements and developing strategies to address emerging issues.

Job Description

The Regulatory Affairs Specialist will be responsible for managing clinical trial applications, regulatory submissions, and pharmacovigilance activities. The successful candidate will have a strong knowledge of EMA regulations and industry best practices, as well as excellent communication and stakeholder management skills.

Main Responsibilities

- Coordinate the preparation and submission of regulatory documents, including clinical trial applications and pharmacovigilance reports.
- Develop and maintain comprehensive knowledge of global regulatory requirements and industry best practices.
- Collaborate with project stakeholders to identify and mitigate regulatory risks.
- Represent the company at regulatory meetings and conferences.

Requirements

- Bachelor's degree in a related field (e.g., life sciences, law).
- Minimum 4-6 years of experience in clinical research or regulatory affairs.
- Strong knowledge of EMA regulations and industry best practices.
- Excellent communication and stakeholder management skills.

What We Offer

- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.

Contact Us

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.

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