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Regulatory Affairs Associate

2 weeks ago

Toronto, Ontario, Canada Apollo Health and Beauty Care Full time

Benefits:

  • Gym Access
  • Dental insurance
  • Health insurance

We're Hiring

About Apollo

At Apollo, we are driven by innovation, quality, and a deep commitment to improving lives through science. Our products are built on research excellence and regulatory integrity. We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our team and play a key role in ensuring our products meet global regulatory requirements throughout their lifecycle.

Position Overview

The Regulatory Affairs Associate will support the development, approval, and maintenance of Apollo's product portfolio by managing regulatory licensing, new product submissions, label compliance, and post-market surveillance. This role collaborates cross-functionally with internal teams and external regulatory partners to ensure compliance, effective submissions, and successful product launches.

Job Responsibilities

  • Designs and implements regulatory strategies to obtain, maintain product, investigative and marketing applications and extend product registrations.
  • Point of contact and accountability for regulatory affairs and management of third-party Regulatory Affairs provider. Manages quality agreements and NDAs.
  • Supports global regulatory assigned projects, working with the external Compliance to form a virtual Global Regulatory Team, including Operations, Labeling, Advertising/Promotion and other functions as required to drive global regulatory strategies.
  • Provides proactive guidance to internal groups based on technical and regulatory knowledge towards the development of strategic and tactical plans for change management involving new product launch.
  • Identify and assess the regulatory risks associated with product development for assigned projects.
  • Manages submission activities of regulatory documents, e.g., NPNs, NDCs, DINs, PIFs, no change notifications, HC/EPA/FDA Establishment Licenses, Biosecurity and HPTA Licenses, NHP site license, Cosmetic notification, voluntary cosmetic reporting program, import/export/free sale/toxic control act/BCB certificates, SDSs, and other relevant regulatory filings.
  • Reviews all labels for regulatory and customer quality compliance.
  • Assessing all complaints and Handling, Evaluating and Reporting of Adverse Drug Reactions complaints
  • Manage Apollo's Pharmacovigilance (PV) activities.
  • Generate Annual Safety Reports for Apollo's OTC products from Solicited and Unsolicited study, literature, and regulatory databases.
  • Manages Supplier's qualification and quality agreements
  • May serve as a corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
  • Can effectively lead key meetings with Formulations Development to ensure full discussion of issues and opportunities.
  • Provides guidance to all appropriate departments to assure compliance with applicable regulations.
  • Remains knowledgeable about current regulations and guidance and interprets and notifies appropriate personnel.
  • Responsible for creating and reviewing regulatory SOPs
  • Perform other duties as assigned

Job Requirements

· Over 5 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing environments

  • Bachelor's degree or diploma in Chemistry, Biology, Engineering, or a related field
  • Strong understanding of cGMP/GDP international regulatory compliance standards
  • Proven Regulatory and Operations experience within a GMP environment
  • Skilled in prioritizing daily activities to meet internal and external customer needs in a fast-paced setting
  • Experienced in working on Quality projects involving data analysis and evaluation of key factors