Product Lifecycle Management Regulatory Specialist
3 weeks ago
We are seeking a highly skilled Product Lifecycle Management Regulatory Specialist to join our team at Apotex. As a key member of our regulatory affairs team, you will be responsible for managing the product lifecycle of Apotex products in identified markets.
Your primary focus will be on ensuring timely approval of quality regulatory PLCM submissions for various markets. You will also be responsible for preparing and reviewing documentation/database records pertaining to approved products, as well as leading/coordinating regulatory affairs projects as assigned.
Responsibilities- Provide support and regulatory guidance to a team in the completion of projects supporting regulatory submissions
- Prepare and review quality regulatory PLCM submissions for various markets to ensure timely approval
- Maintain and complete regulatory documents to support regulatory compliance in various markets
- Assess, coordinate, and compile deficiency responses in a timely manner
- Work with other functional areas to resolve issues related to information for regulatory submissions
- Evaluate, prepare, and review post-approval supplements to manage the regulatory product lifecycle
- Assess change control documents and review change control forms for accuracy
- Maintain regulatory databases to ensure accuracy of information
- Coordinate with third-party manufacturers for document requirements for regulatory submissions
- Act as a backup for team members and support as needed
- Post-graduate/Graduate degree in Chemistry/Pharmacy/Life Sciences
- Minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets
- Knowledge of post-approval change submission requirements and compilation of variation packages for various markets
At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported. We offer accommodation for applicants with disabilities as part of our recruitment process. Our competitive salary is $85,000 per annum, commensurate with experience.
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