Senior Manager – Product Life Cycle Management

Apotex Inc.

Senior Manager leading Regulatory Affairs for product lifecycle management at Apotex. Responsible for regulatory compliance and team management across international markets from Mumbai.

Posted 7/22/2026full-timeMumbai • 🇮🇳 IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Regulatory Affairs, particularly in Product Life Cycle Management (PLCM) and compliance activities, with a strong focus on leading teams, managing regulatory submissions, and ensuring adherence to global regulatory standards. Possesses excellent communication and leadership skills to effectively coordinate cross-functional teams and drive regulatory strategies.

Highest-signal resume keywords

Regulatory Affairs LeadershipProduct Life Cycle Management (PLCM)Regulatory Compliance ExpertiseProject Management PrinciplesTeam Supervision and Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Filing ExperienceChange Assessment ManagementQuality Compliance KnowledgeGeneric New Product DevelopmentPost Approval Management ProcessTechnical Submission ReviewRegulatory Strategy DevelopmentRegulatory Information ManagementKnowledge of Health Agency GuidelinesPerformance Management

Soft Skills

Excellent Communication SkillsLeadership SkillsNegotiation SkillsProblem-Solving SkillsConflict Management Skills

Tools & Technologies

MS-Office SuiteMS-WordMS-ExcelMS-Project

Industry Keywords

Pharmaceutical IndustryRegulatory AffairsGlobal Regulatory PracticesCompliance ProgramsStakeholder Engagement

About the role

Key responsibilities & impact

Responsible for leading Regulatory Affairs individuals accountable for management of life cycle changes including change assessments and submissions all the way to approvals of PLCM (Product Life Cycle Management) projects to support regulatory compliance continued supply of Apotex products
Responsible for Global Regulatory practices to manage regulatory information in various databases and ensure consistent practices and compliance is maintained at Global Apotex sites
This is to be accomplished by planning and managing the activities of the group
Strong linkages need to be established with R&D, Quality, Operations and the Regulatory Market Affiliates/customers (Caribbean, EMEA, GCC, LATAM, APAC and any other international markets as assigned) and Regulatory partners at Global Apotex sites
Responsible for coaching team members via sharing of technical knowledge/expertise
Responsible for planning workload / projects (i.e. change assessments, submissions, training plans, deficiency responses, audits etc.) for international / rest of world markets and managing processes to ensure objectives of department and submission and approval timelines are met
Prioritizes projects in support of commercial business needs
Reviews and ensures timely submission of post-launch variations and completes any other activities as assigned, in a timely manner, to ensure supply continuity for the assigned international markets, through smart regulatory strategies and quality submissions
Handling of deficiencies received from Apotex Affiliates and/or customer and international health regulatory agencies for post-launch variations
Responsible for ensuring timely approval of the PLCM projects with high quality technical submissions and monitoring Agency reviews with the Regulatory Market Affiliate
Develops departmental standards and operating policies and procedures
Provides technical guidance in the review and evaluation of submissions to ensure overall quality and compliance of work
Represents Regulatory Affairs in cross-functional team meetings and provides impact analysis in relevant forums associated with PLCM to support ongoing commercial supply of product
Supports Corporate Business processes (change control, compendia etc.)
Develops & proposes regulatory solutions and escalate action plans for identified product issues to mitigate risks, as required
Challenges the status quo
Develops and maintains effective relationships with external vendors, suppliers, business partners and internal stakeholders in order to ensure business needs are met
Implements business objectives, R&D initiatives and regulatory strategy focusing on process improvements
Regular interactions with stakeholders to discuss on expectations, deliverables/priorities and provide solutions to regulatory issues and/or problems
Stays abreast of changes in regulatory environment / trends and escalates appropriately to ensure that regulatory practices at global Apotex sites are updated as needed
Provides guidance and participates as required in recruitment, training, developing and effective management of ongoing performance of regulatory individuals
Completion of all the assigned trainings in timely manner
Supervises work of direct reports, determining training requirements, performing regular performance reviews and executing development plans in co-ordination with Reporting Manager
Participates and leads 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
Utilizes 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
Creates a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Integrity, Courage, Teamwork, Innovation
Utilizes 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
Ensures adherence of team members (direct reports) with all compliance programs and company policies and procedures
All other duties as assigned

Requirements

What you’ll need

A Graduate/ Post graduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar
Must possess detailed knowledge of the technical, quality compliance, and global regulatory requirements
Excellent communication, presentation, and interpersonal skills
Excellent Leadership, negotiation, problem-solving and conflict management skills
Demonstrated experience in supervising, influencing, and coordinating the complex activities and interaction of staff, including direct and non-direct reports
Strong organisational skills; ability to work independently as well as in dynamic team environment
Strong ability to lead a team of professionals
Demonstrated knowledge of the generic new product development and post approval management process
Excellent understanding of Project Management principles and practice in a complex environment
Excellent oral/written communication in English
Knowledge of recent updated Guidance’s of Health agencies is a must
Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel, and MS-Project (or other PM software)
Should be a Subject Matter Expert (SME) for PLCM activities for international markets
18+ years’ progressive experience pharmaceutical industry
15+ years’ regulatory filing experience with exposure to PLCM & compliance activities for Finished Dosage forms

Benefits

Comp & perks

Apotex is committed to fostering a welcoming and accessible work environment
Accommodation for applicants with disabilities as part of the recruitment process