Job Title

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 RoleReporting to the Director of Regulatory and Clinical, as Senior Regulatory Affairs Associate, you will work with clients on a diverse portfolio of health products and ensure regulatory filings and obligations satisfy the expectations of regulatory compliance. The Senior Regulatory Affairs Associate is an instrumental role supporting the Regulatory and Clinical department providing global development strategies and regulatory advice and preparing/submitting filings within aggressive timelines. This is a primarily remote role, working from home 80% of the time. What You Will DoLead the preparation and filing of submissions to Health Canada and the FDA, 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 (including tasks, timelines and gap analyses).Lead the coordination of regulatory activities on cross-functional project teams, effectively representing regulatory affairs, identifying gaps and solutions, and liaising with other departments (Quality Assurance, product development, analytical, etc.) to obtain information and ensure successful completion of project deliverables.Lead preparation and execution of meetings, ad hoc inquiries and responding to questions from agencies.Perform pharmacovigilance activities (ADR reports, literature/database searches & Annual Summary Reports).Ensure that all work is performed in compliance with SOPs, GxP and regulatory requirements, and maintain current knowledge of these requirements.Contribute to the development/improvement of internal regulatory procedures.Assess change controls and contribute to the planning/implementation of changes.Maintain regulatory documentation, filing systems, spreadsheets, databases, etc. Independently lead the preparation and submission of 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.Lead or contribute to the preparation, review and updates of regulatory (e.g., Investigators Brochures, Product Monographs, product labels, clinical protocols) and quality documents. 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 AtomVies overall goals.Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality. Understand and work under the Health Canada and FDA GMP and other regulatory requirements for applicable product types.Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work. RequirementsCompletion 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 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. Experience with the corresponding submission types to the FDA is an asset.What You Bring to the RoleDemonstrated 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 OffersGroup Health & Dental Benefits (from day 1)RRSP Matching ProgramPerkopolisEmployee Assistance and Wellness ProgramsParking AllowanceAtomVie 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.