Associate, Regulatory Affairs

1 month ago

North York, Canada Apotex Inc. Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**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.

**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

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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