Regulatory Affairs Associate

Toronto - Canada

Monthly Salary: Not Disclosed

Posted on: 07-11-2025

Vacancies: 1 Vacancy

Job Summary

Benefits:

Gym Access
Dental insurance
Health insurance

Were 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 Apollos 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 Apollos Pharmacovigilance (PV) activities.

Generate Annual Safety Reports for Apollos OTC products from Solicited and Unsolicited study literature and regulatory databases.

Manages Suppliers 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

Bachelors 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

Required Experience:

Benefits:Gym AccessDental insuranceHealth insuranceWere 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 R...