Asst Mgr, GBS GRA PLCM

About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

• Leads and manages a Regulatory Affairs team based in Mumbai in the following:

• The review, compilation and submission of post launch variations and deficiency responses.

• Handling assessment of change control records (CCR).
• Maintenance of product documentation and database records.
• Initiation and implementation of department-driven projects.
• Monitors and reports on the progress/status of submissions, planned changes to the Reporting Manager
• Provides coaching to team members via sharing of technical knowledge/expertise
• To review submission and / or approval notifications for PLCM variation application submitted to Regulatory agencies.
• Support to set up new process (as applicable) within team and ensure smooth transition and functioning.

Job 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.

Works as a member of a team to achieve all outcomes.

Completion of all the assigned trainings in timely manner.

Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.

Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.

Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.

Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.

Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.

All other duties as assigned.

Job Requirements

• Education:

• 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.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer 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.