Global Regulatory Coordinator

5 days ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

About Us



At AtomVie Global Radiopharma Inc., we are dedicated to advancing high-quality drugs for the treatment and diagnosis of diseases. Our team is passionate about transforming patients' lives and making a meaningful impact in the healthcare industry.



We are a community that values diversity, equity, and inclusion, and we are committed to fostering a workplace that promotes these values. We believe in empowering our employees to grow and develop their careers, and we offer opportunities for professional growth and development.



Job Role

This position is responsible for working closely with clients on a diverse portfolio of health products, ensuring regulatory filings and obligations satisfy the expectations of regulatory compliance. The ideal candidate will have a strong understanding of regulatory affairs and be able to develop and implement global development strategies.



Key Responsibilities


  • Prepare and submit regulatory filings for investigational and commercial radiopharmaceuticals, including CTAs, INDs, commercial market applications, and ongoing maintenance/post-clearance submissions.
  • Develop and communicate regulatory project planning and strategic regulatory advice/plans for internal and external stakeholders.
  • Perform pharmacovigilance activities (ADR reports, literature/database searches & Annual Summary Reports).
  • Maintain current knowledge of regulatory requirements and ensure all work is performed in compliance with SOPs, GxP, and regulatory requirements.


The ideal candidate will have excellent communication and interpersonal skills, as well as the ability to work independently and as part of a team. They will also be required to maintain confidentiality and handle sensitive information appropriately.



Requirements

To be successful in this role, you will need:




  • Completion of a post-graduate Regulatory Affairs certification course.
  • A degree in a scientific field, preferably biological sciences or chemistry; Sc. in these fields is an asset.
  • Minimum 3-4 years working in Canadian Regulatory Affairs, including direct experience with commercial new drugs (NDS and related filings) and/or investigational (CTA and related filings) submissions.
  • Demonstrated experience directly preparing/reviewing administrative, CMC, and/or clinical submission components.
  • Ability to work independently, learn quickly, take initiative, have high quality standards, and possess excellent organizational skills.


Benefits

We offer a comprehensive benefits package, including Group Health & Dental Benefits, and opportunities for professional growth and development.

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