AtomVie Global Radiopharma Inc. is a global leading Contract Development and Manufacturing Organization (CDMO) that manufactures investigational and commercial radiopharmaceuticals. We work with our partners to transform patients' lives by advancing high quality drugs for the treatment and diagnosis of diseases.

We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

About The Role

The Regulatory and Clinical department works with a variety of clients to provide global development strategy and regulatory advice, and prepare/submit filings within aggressive timelines. Reporting to the Director, Regulatory and Clinical, the Regulatory Affairs Associate will prepare and file submissions to Health Canada & the FDA, including CTAs, INDs, commercial market applications and ongoing maintenance/post-clearance submissions.

This is a 16-18 month contract position, with Group Health & Dental Benefits (from day 1 of contract) and remote work 80% of the time.

What You Will Do

• Prepare, publish and submit regulatory filings for investigational drugs, marketed drugs, Drug Master Files, and establishment licensing (Health Canada and FDA). Submission activities include drafting and reviewing administrative/clinical/CMC sections, and publishing.
• Prepare, review and update regulatory (e.g., IBs, Product Monographs, product labels) and quality documents.
• Contribute to regulator interactions such as consultation meetings or responding to inquiries.
• Liaise with other departments (e.g., QA, product development, analytical) and clients to obtain information to ensure successful completion of project deliverables.
• Perform pharmacovigilance activities (ADR reports, literature/database searches & Annual Summary Reports).
• Contribute to the development/improvement of internal regulatory procedures.
• Ensure that all work is performed in compliance with SOPs, GxP and regulatory requirements, and maintain current knowledge of these requirements.
• Assess change controls and, where required, contribute to the planning/implementation of changes.
• Maintain regulatory documentation, filing systems, spreadsheets, databases, etc.
• Provide clear, accurate, and timely feedback to the direct manager about project status.
• Any other assigned duties to support the Regulatory and Clinical department and AtomVie's overall goals.

Requirements

• Completion of a post-graduate Regulatory Affairs certification course required.
• B.Sc. in a scientific field, preferably biological sciences or chemistry; an M.Sc. in these fields is an asset.
• Minimum 1-2 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. Experience with the corresponding submission types to the FDA is an asset.

What You Bring to the Role

• Demonstrated experience directly preparing/reviewing administrative, CMC and/or clinical submission components (e.g., Module 1 documents, Module 2 summaries, Module 3.2 sections) and with publishing.
• Background with prescription pharmaceutical products; experience with radiopharmaceuticals and/or sterile products is an asset.
• Ability to work independently, learn quickly, take initiative, have high quality standards, and possess excellent organizational skills.
• Excellent attention to detail and the ability to quickly summarize and analyze scientific data.
• Strong proficiency in the English language with excellent verbal and written communication skills, and the ability to present solutions and strategies in a clear and concise manner.
• Must be client-focused with the ability to understand client needs and diplomatically advise of risks or alternative strategies.
• Proficient with MS Office (Word, Excel, Powerpoint, etc.) and Adobe software; experience with eCTD publishing is an asset.

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.