Project Management Executive - Pharmaceutical Product Lifecycle

Executive - Project Managment

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.

For more information visit: www.apotex.com.

 

Job Description

Job Title (Internal)

Executive

Job Profile/Level:

JM3

Line of Business (LOB) or Business Process Stream (BPS)

AGO-ARPL

Department/Org Unit:

ARPL - Network optimization Strategy

Reports Directly To:

Senior Manager

Reports Indirectly To:

NA

People Leader

No

Number of Direct Reports and Job Titles

Nil

Effective Date

(Month / Day / Year)

Revision Date

(Month / Day / Year)

NA

Revision Number:

00

Job Location:

ARPL Bangalore

Travel Requirements

No

Job Summary

The Product Change & Lifecycle Management Coordinator supports end-to-end product lifecycle activities, site transfers, regulatory compliance, and project tracking to ensure timely delivery, quality, and adherence to global standards in pharmaceutical manufacturing.

Job Responsibilities

• Develop and execute comprehensive Product Change Management strategies aligned with business goals and regulatory standards.
• Coordinate cross-functional teams (R&D, Regulatory, Manufacturing, Planning) to ensure seamless product lifecycle management.
• Oversee regulatory submissions, amendments, and renewals throughout the product lifecycle.
• Lead lifecycle activities such as New Source Qualification, Source-Driven Changes, 3P Site transfers, packaging variations, and label updates.
• Ensure compliance with global and local pharmaceutical regulations (GMP, GDP, etc.).
• Prepare and monitor monthly plans to meet scheduled milestones for product lifecycle activities.
• Support site transfer projects by planning, coordinating, finalizing supply plans, confirming API/excipient availability, conducting risk assessments, transferring technology, and procuring change parts within timelines.
• Track project progress through regular stakeholder meetings, escalate bottlenecks, and evaluate risks for mitigation.
• Manage Regulatory Affairs documents for all ROW markets, monitor submission timelines, and coordinate stakeholder updates for timely approvals.
• Ensure on-time availability of APIs, raw materials, packaging, documentation, and final dispatch for market supply.
• Anticipate and mitigate risks related to API/RM delays, process issues, supply changes, and schedule disruptions; escalate critical risks to senior management.
• Report any non-compliance issues immediately to supervisors.
• Collaborate as part of a team to achieve business objectives, adhering to the “Right First Time” principle.
• Comply with all relevant regulations, including Global Business Ethics and Quality standards.
• 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.
• Utilize open, honest, two way communication to build trust-based relationships with collegues, 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.
• Demonstrate winning behaviors of Individual accountability, Rigor and discipline & continuous improvement throughout.

Job Requirements

• Education
  • Pharm / M.Pharm (MBA or any project management certification is preferable).
• Knowledge, Skills and Abilities
  • Good understing of the manufacturing process development, Scalability and Equipment principles.
  • Documentation and data management related to the technology transfer related to activity.
  • Abitity to cummunicate and collaborate the all cross functional team and meet the deadline as per the goal.
  • Experience in preparation and review of technology transfer document.
  • Well versed with Microsoft Office (Project, Word, Excel and Powerpoint).
  • Experience in PM tools (Planner & BI dashboard).
• Experience
  • 3-5 years experience

At Apotex, we are committed to fostering a welcoming and accessible 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.

 

Experience Level

Executive Level