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Associate Director, Regulatory Affairs
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Mississauga, Canada Novo Nordisk AS Full timeOverviewSelect how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Mississauga, Ontario, CAClinical, Medical & Regulatory DepartmentMississauga, CanadaAre you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? Do you have a strong strategic vision and...
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Associate Director, Regulatory Affairs
4 weeks ago
Mississauga, Canada Novo Nordisk AS Full timeOverviewSelect how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Mississauga, Ontario, CAClinical, Medical & Regulatory DepartmentMississauga, CanadaAre you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? Do you have a strong strategic vision and...
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Associate Director, Regulatory Affairs
4 weeks ago
Mississauga, Canada Novo Nordisk AS Full timeOverview Select how often (in days) to receive an alert: Create Alert Category: Reg Affairs & Safety Pharmacovigilance Location: Mississauga, Ontario, CA Clinical, Medical & Regulatory DepartmentMississauga, Canada Are you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? Do you have a strong strategic vision and...
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Associate Director, Regulatory Affairs
4 weeks ago
Mississauga, Canada Novo Nordisk AS Full timeOverviewSelect how often (in days) to receive an alert: Create AlertCategory: Reg Affairs & Safety PharmacovigilanceLocation: Mississauga, Ontario, CAClinical, Medical & Regulatory DepartmentMississauga, CanadaAre you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? Do you have a strong strategic vision and...
Senior Associate, Regulatory Affairs
4 weeks ago
OverviewSun Pharmaceuticals Industries Inc. is the fifth largest generic pharmaceutical company in the world, and is rapidly building a branded product presence globally and specifically in Canada. Sun Pharma Canada Inc. has a team of 70 plus employees and a portfolio of 5 commercial products in the branded business and a pipeline of molecules in development. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately help patients.At Sun Pharma Canada Inc. we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values: Humility. Integrity. Passion. Innovation.ResponsibilitiesAssist with planning, preparing, coordinating, compiling, reviewing and submitting regulatory dossiers (e.g., NDS, SNDS, NC, Level III Changes) to Health CanadaPrepare responses to Health Canada clarification requests in a timely manner throughout the submission lifecycleMaintain current drug product registrations and support post-approval regulatory activitiesReview product packaging, labeling, and promotional materials for complianceReview change controls and assess impact of regulatory updates and support implementation of necessary changesTrack submission milestones and post-approval commitmentsSupport product launch activities from a regulatory perspectiveSupport regulatory strategy development for new product filings and lifecycle managementMonitor and interpret changes in Canadian regulatory guidanceMaintain accurate and organized regulatory documentationWork closely with departments including Quality, R&D, Marketing, and Supply ChainOther regulatory responsibilities as required by the DirectorAdditional Responsibility (Only Applicable To Customer Facing Roles)Report any adverse event received from customers for company products to the pharmacovigilance/drug safety department within 1 business dayQualificationsKnowledge, Skills and AbilitiesFamiliarity with Health Canada regulatory guidelines and submission processes (including chemistry and manufacturing, labeling and format requirements)Ability to interpret regulations and create compliant documentationStrong interpersonal, written and verbal communication skillsExcellent organizational and time-management abilities to adhere to submission timelinesComfortable working on multiple priorities and deadlinesHigh attention to detail and accuracyCollaborative and adaptable in fast-paced environmentsProactive problem-solving mindset with a focus on compliance and qualityProficiency with Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat and document management systemsKnowledge of GMP requirements and QA/QC proceduresBackground And ExperienceBachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related fieldPostgraduate studies or certification in Regulatory Affairs (e.g., RAPS, TOPRA) is an asset3 - 7 years of drug regulatory affairs experience within the pharmaceutical / healthcare industry specifically in branded or innovative medicinesWorking conditionsLocal Canadian officeExtensive use of computerVaried work schedule to meet deadlines, as requiredPhysical RequirementsHybrid role (in office at least 3 days a week)Seniority levelMid-Senior levelEmployment typeFull-timeJob functionLegalIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at SUN PHARMA by 2xGet notified about new Regulatory Affairs Associate jobs in Mississauga, Ontario, Canada. #J-18808-Ljbffr
