Associate, Regulatory Affairs

Job Summary

Responsible for compilation and submission of dossiers for registration of Apotex products in identified markets. Also responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.

Job Responsibilities

• Responsible for the preparation and peer review of quality regulatory submissions for various markets to ensure timely approval
• Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
• Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.
• Works with other functional areas to resolve issues related to information for regulatory submissions.
• Prepare and peer review labelling, product monographs and marketing materials.
• Evaluate, prepare and peer review of post approval supplements to manage the regulatory product life cycle as applicable.
• Review of change control documents.
• Approval of change control documents and quality notifications as assigned.
• Assist in product launch activities as required.
• Maintains regulatory databases to ensure accuracy of information.
• Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
• Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
• Contribute to the creation and promotion of an environment of teamwork and empowerment.
• Resolve complex issues relating to submissions.
• Interprets and makes decisions relating to regulatory guidelines and policies.
• Leadership/Professional Development of Self & Others
• Addresses complex regulatory activities in support of submissions.
• Assist in training of more junior staff.
• Seeks guidance from other team members to enhance regulatory knowledge.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education

                  BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences. Diploma from a

                  RA program would be an asset.

• Knowledge, Skills and Abilities

• Excellent communication, presentation and interpersonal skills
• Knowledge of Canadian ,US, EU, AUS and other International markets (as applicable) regulatory guidelfnes is a must
• Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel

• Experience

• 3-5 years progressive experience the pharmaceutical industry