Regulatory Affairs Manager

JOB OBJECTIVES

The Regulatory Affairs Manager, reporting to the Head of Scientific Affairs will play a critical role in leading the Regulatory Team, managing regulatory submissions and ensuring compliance with Health Canada and US FDA regulations, and, fulfilling the role of Subject Matter Expert (SME) in Health Authority requirements for pharmaceutical products registered and sold by Juno Pharma Canada Inc. or through strategic partnerships abroad. This position involves strong operational skills, strategic planning, leadership, and direct communication with regulatory authorities to secure product approvals.

PRIMARY FUNCTIONS

• Regulatory Team Leadership: Provide direction to Regulatory Team members and ensure attainment of key corporate filing objectives. Review Team member performance and encourage growth and professional development.
• Regulatory Strategy: Assist in the development of product regulatory strategies that ensure timely product approval and market entry. Represent Juno Pharma Canada in broader industry regulatory frameworks by participating in key industry advisory committees.
• Product Due Diligence: Oversee and conduct due diligence and gap analysis of prospective products and development candidates to assess critical risk and determine the likelihood of attaining timely regulatory approvals.
• Regulatory Submissions: Assess technical product information provided by in-licensing partners and internal development partners for completeness, reasoning and rational to meet Health Authority requirements for new drug products and compliance with marketed product authorizations. Direct actions partner actions to address gaps to increase potential to gain regulatory approvals in a timely manner. Ensure the high quality of submissions produced within the Team. Compile, write, and publish electronic regulatory submissions (e.g., ANDS, Cross Licence Applications) to Health Canada and various other regulatory submissions to US FDA. Prepare and file administrative submissions and supplementary submissions as necessary to support product lifecycle and maintain compliance with regulatory requirements.
• Compliance Management: Ensure all submissions meet with Health Canada requirements and address any deficiencies (e.g., Notices of Non-Compliance, Notices of Deficiency). Propose persuasive and compelling scientific arguments where needed.
• Documentation Review: Perform thorough reviews of submission documentation and provide guidance to Team members, stakeholders and development partners. Assess proposed change control initiatives for the potential impact to product registrations and advise the change control initiator of the regulatory impact of the proposed change.
• Product Labelling: Ensure the preparation and update product labelling, including Product Monographs, and coordinate French translations.
• Stakeholder Communication: Liaise with Health Canada and internal/external stakeholders to support regulatory submissions.
• Training and Mentorship: Assist in training and guiding less experienced staff members.
• Regulatory Updates: Stay up to date with applicable regulatory guidelines (Health Canada, FDA, EMEA, ICH, etc.) and develop departmental guidelines.

REQUIREMENTS AND SKILLS

• Bachelor’s degree (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry, or related Health Sciences.
• Post secondary training in regulatory affairs and certification by Regulatory Affairs such as: Certification (RAC) and (RAC CAN); Certified Regulatory Compliance Manager (CRCM): and Certificate in Pharmaceutical Regulatory Affairs offered by a recognized university or college that is tailored to regulatory processes in the pharmaceutical industry, it’s an asset.
• Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry with key emphasis on Generic solid oral dosage forms and Generic sterile dosage forms. Prior leadership experience is a key asset.
• Skills: Strong attention to detail, excellent organizational and communication skills and ability to work independently and lead a team of regulatory professionals.
• Technical Proficiency: Demonstrated skill as a SME in regulatory matters and familiarity with regulatory submission software and databases. Strong knowledge of Health Authority new product approval requirements and, familiarity with regulatory submission software and databases.
• Language Skills: Bilingual (English/French) and excellent written and oral communication skills.
• Attention to Detail: Precision in reviewing and preparing regulatory documents to ensure compliance with Health Canada regulations.
• Organizational Skills: Ability to manage multiple submissions and projects simultaneously, maintaining clear and accurate records.
• Communication Skills: Strong written and verbal communication skills for effective interaction with regulatory authorities and internal stakeholders.
• Analytical Skills: Capability to analyze regulatory guidelines and data to develop strategic submission plans.
• Problem-Solving: Ability to address and resolve regulatory issues and deficiencies. Proven ability to propose sound scientific arguments and justifications where necessary to secure product approvals.
• Leadership and Mentorship: Direct experience in guiding and training junior staff members.
• Up-to-date Knowledge: Staying informed about current regulatory guidelines and industry trends.

*Location: Montreal.