Associate, Regulatory Affairs Job Vacancy in Mint Pharmaceuticals Inc. Mississauga, ON – Latest Jobs in Mississauga, ON

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Company Name : Mint Pharmaceuticals Inc.
Location : Mississauga, ON
Position : Associate, Regulatory Affairs

Job Description : About Mint Pharmaceuticals Inc.Canadian owned and operated, Mint Pharmaceuticals Inc. (“Mint”) is a leading manufacturer of high quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one of the fastest growing and most reputable pharmaceutical companies in Canada. Since 2014, the company has averted 16 national drug shortages on 10 different drugs through its best-in-class supply chain management. For 3 consecutive years, the company was recognized by Deloitte and CIBC as one of Canada’s Best Managed Businesses.Position: Regulatory Affairs, AssociatePrimary Functions: We are currently seeking a self-motivated individual to join the Regulatory Affairs team. The successful candidate will be a critical team member responsible for preparation and submission of various regulatory submissions (primarily CMC documents) for new or marketed generic products to Health Canada or external stakeholders. This position offers a great opportunity for professional development with a rapidly growing Canadian company.Roles and Responsibilities: Prepare and submit various regulatory submissions in the CTD format to Health Canada.Preparing product labelling and monograph in compliance with Health Canada’s 2020 template.Ensures that submissions are accurate, complete, and compliant with regulatory requirements.Create, review, and maintain documents and standards within Regulatory Affairs.Perform regulatory risk assessment by identifying, describing and estimating the risks affecting current and future development projects.Prepare responses to questions raised by Regulatory Authorities or business partners in a timely manner and within deadlines.Perform gap analysis on dossiers to identify weakness for ANDS submission to Health CanadaCommunicate and coordinate with partners/manufacturers to obtain supporting documents for ANDS submission.Responsible for assessing, coordinating, and compiling deficiency responses in a timely manner to deficiency questions from Health CanadaSupport internal and external groups to assist with product listing on all the provincial formulariesResponsible for post-market product administration, participating in the review and evaluation of planned changes for impact on regulatory submissions, identifying regulatory filing requirements and recommending regulatory agency and customer notification strategies/plans in the affected regulatory jurisdictions.Evaluate proposed changes to development and marketed products for regulatory impact and liaise with internal/external stakeholders to assemble necessary documentation.Assist in developing and maintaining various regulatory tracking tools.Work closely with all functional groups (Business Development, Legal, Production, Quality, R&D) within and outside (manufacturing partners) the company to ensure all regulatory obligations are met.Manage collaborations with external partner sites for new projects. Serve as main point of contact with third-party manufacturers for the projects led.Maintains awareness of current regulatory environment and guidelines that impact the organization and share knowledge with internal stakeholders, as required.Support implementation of QA systems and generation of Standard Operating Procedures.Remain up to date on applicable regulatory guidelines (Health Canada, ICH, etc.).Perform other duties as required or necessaryNote: Any other duties as assigned by Senior Scientific and Regulatory Affairs Leadership team.Major Tasks: SubmissionsReviewing dossiers shared by partner companies for regulatory submissions for completeness, accuracy and compliance with regulatory requirements and providing feedback to partners.Compilation of product labelling material.Reviewing Drug Master Files and providing gap assessments to partners.Preparation of regulatory submissions (CTD format) including compiling, writing, and publishingNegotiation with regulatory authorities to gain approval (NOC) and obtaining alignment from partners and other functional groups on responses.Timely preparation and filing of submissions to support company needsSupervision and coordination with outside consultants, subject matter experts relating to the preparation of regulatory submissions and other related regulatory activities, as required.Product Assessments/ Product LaunchesMonitoring product development activities by interacting contract manufacturers as necessary against identified submission targets.Provide impact regarding formulation of drug development, clinical development etc. Initiation of Change Controls for changes from submission documents to launch documents, for handover to Quality Department.LabellingPrepare, review and approve artwork/labelling.ComplianceEnsure continual regulatory compliance of all products due to changes initiated from HC (e.g. Labeling, Quality, changes).Help to develop and oversee procedures and processes within Regulatory Operating Procedures to ensure compliance applicable regulations (e.g. Working Instructions are up to date, SOPS are followed etc.)Assist in development and maintenance of accurate databases.Overseeing the timely preparation of activities for other functional groups (SAP codes creations, launch documentation packages.Skills & Qualifications:Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry or related Health SciencesMust have strong technical knowledge of CMC requirements and is able to critically analyze scientific dataStrong knowledge of CTD requirements for drug submissions.Knowledge of electronic submissions, including e-publishing (e.g., Docubridge)Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally)Strong working knowledge of Canadian Food and Drugs Act and Food and Drug Regulations, GMPs, ICH Guidelines and Health Canada Policies and GuidelinesAbility to prioritize workload to ensure all deadlines are metExcellent organization, written and oral communication skillsAbility to effectively manage multiple projects in a fast-paced, results oriented environmentStrong commitment to quality, accuracy, and detailAbility to work well under pressure in a team-based environmentJob Types: Full-time, PermanentSalary: $28,694.00-$153,961.00 per yearSchedule:Monday to FridayAbility to commute/relocate:Mississauga, ON L5T 2M3: reliably commute or plan to relocate before starting work (preferred)

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