Manager, Proj Mgmt - Bioequivalence

Apotex Inc.; Bengaluru; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Apotex Inc. in Bengaluru seeks a senior project leader to oversee end-to-end Bioequivalence studies, BE, Patient PK, POC, and 505(b)(2) programs.

You will drive feasibility, planning, CRO oversight, risk management, and timely delivery of milestones from study setup to final archival. The role requires deep expertise in regulatory coordination, quality compliance, and cross-functional leadership across Clinical Operations, Regulatory Affairs, and QA.

Qualifications

• Minimum of 15 years of experience in clinical project management.
• Expertise in BE studies, Patient PK, POC and 505(b)(2) programs.
• Strong CRO/vendor oversight and budget/risk management.
• Excellent communication and leadership skills.
• MBA or MSc/MPharm preferred with regulatory knowledge.

Responsibilities

• Lead end-to-end BE, PK, POC, and 505(b)(2) studies; feasibility through final report.
• Oversee CROs and vendors; ensure quality, timelines and budgets.
• Coordinate regulatory submissions and inspection readiness.
• Maintain project dashboards, risk registers, trackers, and KPI metrics.
• Collaborate with Clinical Operations, Regulatory Affairs, Data Management, and QA.
• Provide regular updates to leadership and sponsors.

Skills

Bioequivalence

Project Management

Patient PK Studies

POC & 505(b)(2) Programs

CRO Oversight

Risk & Budget Management

Communication & Interpersonal skills

Change Management

Drive for Results

Planning & Prioritizing

Leadership

Judgement & Decision Making

Education

M.Pharm./ MSc. / MBA

Job description

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.

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 Summary

• Lead and manage end-to-end execution of Bioequivalence (BE), Patient PK, POC, 505(b)(2), and CRO-outsourced clinical studies. Responsible for project planning, stakeholder management, CRO oversight, regulatory coordination, risk mitigation, budget control, and timely delivery of study milestones from feasibility through final report and archival

Job Responsibilities

• Project Leadership
• Serve as the single point of accountability for assigned studies and clinical programs.
• Develop project plans, timelines, resource allocation, budgets, and risk mitigation strategies.
• Drive on-time delivery of project milestones, reports, and study closures.
• Clinical & Study Management
• Oversee execution of BE, Patient PK, POC, and 505(b)(2) studies.
• Ensure study objectives are achieved while maintaining quality, compliance, and timeline commitments.
• Monitor critical path activities and proactively resolve operational issues.
• CRO & Vendor Management
• Identify, qualify, and manage CROs, laboratories, and vendors.
• Track CRO performance, study deliverables, budgets, and compliance metrics.
• Escalate and resolve project risks impacting scope, quality, cost, or timelines.
• Regulatory & ComplianceCoordinate regulatory submissions, ethics approvals, and inspection readiness.
• Ensure compliance with GCP, SOPs, protocol requirements, and applicable global regulations.
• Cross-functional Coordination
• Collaborate with Clinical Operations, Bioanalytical, Regulatory Affairs, Data Management, Medical Writing, QA, Supply Chain, and Sponsors.
• Facilitate effective communication and alignment among all stakeholders.
• Governance & Reporting
• Maintain project dashboards, risk registers, trackers, and KPI metrics.
• Provide regular project updates and management reports to leadership and sponsors.

Job Requirements

• Education
• Minimum M.Pharm./ MSc. / MBA.
• Knowledge, Skills and Abilities
• Minimum of Advanced proficiency level in
• Bioequivalence studies
• Project Management
• Patient PK Studies
• POC & 505(b)(2) Programs
• CRO & Vendor Oversight
• Risk & Budget Management
• Communication & Interpersonal skills.
• Change Management
• Drive for Results
• Planning & Prioritizing
• Leadership
• Judgement & Decision Making
• Experience
• Minimum 15 years of experience

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