Manager Lead Associate Regulatory Affairs

We are seeking Manager / Lead Associate for our Regulatory Affairs team in Canada. Incumbent will support and execute all Canadian regulatory activities including product lifecycle management Natural Health Product (NHP) submissions promotional materials review and pre-clearance submissions labelling updates and crossfunctional regulatory support. The role ensures ongoing compliance with Health Canada regulations and enables timely product launches continued market access and effective maintenance of the marketed portfolio.

Responsibilities:

• Natural Health Products Submissions & Lifecycle Management
  • Prepare and submit NHP product license applications amendments notifications and post-licence updates
  • Support post-approval life cycle management including review of change controls and updates to maintain compliance with the NHP regulations
• Regulatory Labelling Supplements
  • Create maintain archive all regulatory labelling submissions
  • Conduct labeling artwork reviews and ensure alignment with Health Canada regulatory requirements
  • Review all Module 1 documents for completeness and compliance prior to submission.
  • Manage responses to deficiency comments by coordinating with global teams and ensuring alignment with Health Canada expectations
• Contract Manufacturing Operations (CMO) Support
  • Provide regulatory oversight and lifecycle management support for the marketed products manufactured by CMOs 
  • Perform regulatory impact assessments for CMO change controls ensuring brand safety updates are filed on time and maintain the CPID throughout the product lifecycle
• Promotional Materials Compliance & Submissions
  • Serve as the Regulatory SPOC on the Promotional Review Committee (PRC) reviewing all promotional materials in compliance with regulations
  • Determine whether promotional materials require submission to PAAB (prescription drugs) or Ad Standards (NHPs) and independently prepare and submit required applications
  • Track renewal timelines and complete renewal submissions to ensure ongoing promotional compliance
• Certificate of a Pharmaceutical Product (COPP)
  • Prepare and submit COPP applications to support ROW commercial requirements
  • Support Apostile process required for global market documentation
• Ad-hoc Regulatory Support
• Support Canada Regulatory Lead in preparing and managing new drug submissions postapproval supplements and presubmission correspondence with Health Canada
• Annual Drug Notification (ADNF) Submissions: Coordinate with cross-functional teams to identify discontinued products plan required labelling updates and update the DEL as applicable
• Product Launch Support:
  • Prepare Drug Notification Form (DNF) to notify Health Canada of product launches
  • Support Marketing with regulatory documentation required for Requests for Proposals (RFPs) and formulary listings
• Special Access Program (SAP):
  • Support submissions for designated drugs (e.g. cycloserine disopyramide)
  • Prepare initial applications risk communications and pre-importation notifications
• Risk Management Plans
  • Support Pharmacovigilance with eCTD submissions for RMPs
  • Submit Risk Management materials to PAAB for pre-clearance prior to implementation
• eCTD Publishing: Perform eCTD sequence review and publishing as needed including troubleshooting validation errors
• Provide support to the broader North America Regulatory Affairs team with U.S. pre and postmarket submission activities as needed
• Regulatory Intelligence: Conduct continuous monitoring of regulatory and guidance updates and proactively communicate relevant changes to stakeholders

Qualifications :

Educational qualification: BS/MS degree in Pharmacy/Chemistry 

Minimum work experience: 7 years of generic regulatory experience in pharmaceutical industry; Experience with US FDA (Food and Drug Administration) / brand regulatory would be a plus

Skills & attributes:

• Strong understanding of the Canadian pharmaceutical and Natural Health Products (NHPs) regulatory requirements
• Thorough knowledge of Health Canada regulations and guidance as well as GMP and DEL requirements applicable in Canada
• Knowledge of regulatory submission formats eCTD structure and filing categories
• Strong oral and written communication skills
• Strong organizational skills attention to detail and flexible
• Excellent time-management skills with the capability to manage multiple concurrent projects and shifting priorities

Additional Information :

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
 
Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion age sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against based on disability.

For more details please visit our career website at

Remote Work :

No

Employment Type :

Full-time