Assistant Manager - Global Regulatory Affairs

Job Description:

Responsibilities

• Schedules, prioritizes and assigns projects [i.e. PLCM submissions and deficiency responses. Review of change control record assessment (CCR), supplier driven changes (SDC) & pre-CMC changes and other department-driven projects etc.] to Regulatory Affairs team members to ensure business timelines are met.
• Review and ensure that timely submission of post-launch variations applications of assigned projects.
• Handling of deficiencies received from Apotex Affiliates and/or customer and health regulatory agencies for post-launch variations.
• Ensure documents are of high-quality standard to ensure one cycle review from Regulatory authorities.
• Support reporting manager in identifying high performers within team and prepare their development plan.
• Review of databases and established trackers to ensure accuracy of information (Review checklist for PLCM submission /deficiency response deficiency tracker, submission spreadsheet etc.)
• Supervises work of direct reports, determining training requirements, performing regular performance reviews and executing development plans in co-ordination with Reporting Manager.
• Regular interactions with stakeholders to discuss on expectations, deliverables/priorities and provide solutions to regulatory issues and/or problems.
• Works with other functional areas to resolve issues related to regulatory submissions, compliance, and internal processes.
• Coaches, trains and provides guidance to other team members in the preparation of quality submissions and other functional tasks.
• Acts as a back-up for other team members and as a designate to the Reporting Manager, as required.
• Contributes and encourage team members towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect.

Qualification & Experience

• A Graduate/ Post graduate degree in Chemistry/Pharmacy/Scientific/business discipline or similar.
•  Knowledge, Skills and Abilities:
•  Candidate should have knowledge about Post approval changes submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets.
• Experience:
•  Should have minimum 11 years of regulatory affairs experience in US/CAN/EU/AUS-NZ/ROW markets.
•  Experience in CMC document writing and review.
• Minimum 4 years of experience in managing a team.