Manager - New Product Development International

Apotex Inc.; Mumbai; On-site; INR 2,500,000 - 3,600,000; Full time

Job summary

Apotex Inc. is seeking a senior Regulatory Affairs leader responsible for managing international product registration activities, compiling and submitting dossiers, addressing deficiencies, and ensuring global regulatory practices across LATAM, APAC, EMEA, and more.

The role involves coaching the team, coordinating with R&D, Quality and Operations, and driving process improvements. The candidate should have extensive experience in NPD dossiers for international markets, strong project management

Qualifications

• Detailed knowledge of technical, quality compliance and global regulatory requirements.
• Experience in supervising and coordinating complex activities with direct and indirect reports.
• Proven ability to manage cross-functional teams and multi-market regulatory submissions.

Responsibilities

• Schedule and assign regulatory projects to ensure timelines are met.
• Review, compile and dispatch new product submissions and pre-launch variations.
• Handle deficiencies from regulatory agencies and affiliates on submissions.
• Ensure high-quality documents for regulatory reviews and approvals.
• Monitor progress of submissions and product launches; report to the manager.
• Coordinate with third-party manufacturers for document requirements and responses.

Skills

Leadership

Regulatory affairs

Project management

Communication

Team coordination

MS-Office

NPD dossiers

Tools

MS-Word

MS-Excel

MS-Project

Job description

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

Responsible for leading Regulatory Affairs individuals accountable for management of new product registration activities in international markets that include compilation, review & submission of new product registration dossiers, deficiency responses and pre-launch variations etc. Perform due diligence and help cross-functional teams in planning, prioritizing & tracking of planned dossier dispatches/submission and launches respectively. Also 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. Establish strong linkages with R&D, Quality, Operations and the Regulatory Market Affiliates/Customers (LATAM, APAC, Caribbean, EMEA, GCC, EU and AUS-NZ market) and Regulatory partners at Global Apotex sites. Implement department-driven projects & support to set up new processes (as applicable) within team and ensure smooth transition & functioning. Responsible for coaching team members via sharing of technical knowledge/expertise

Job Responsibilities

• Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met.
• Review, compile and dispatch new product submissions and pre-launch variations.
• Handling of deficiencies received from Affiliates and/or customer and health regulatory agencies on the new product submissions and pre-launch variations.
• Ensure documents are of high-quality standard to meet one cycle review from Regulatory authorities.
• Review submission and / or approval notifications for new product applications submitted to Regulatory agencies.
• Monitors and reports on the progress/status of submissions, planned changes and product launches to the Reporting Manager.
• Support reporting manager in identifying high performers within team and prepare their development plan.
• Co-ordinate with third party manufacturers for document requirement and query response (as required) of in-licensed projects.
• Review of database and trackers to ensure accuracy of information.
• Regular interactions with stakeholders to discuss expectations, deliverables/priorities.
• Manage CCR related activities such as CCR assessment, document verification and closing of RA approval tracker.
• Works with other functional areas to resolve issues related to regulatory submissions, compliance and internal processes.
• Monitors and reports on the progress/status of projects to the Reporting Manager and other functional groups (as applicable).
• Actively works with reporting manager to suggest, develop and obtain own Key Performance Measures.
• Act as a back-up for other team members and as a designate to the Reporting Manager, as required.
• Liaises with functional groups to request and/or provide documents relevant to new product submissions, deficiencies, pre-launch variation.
• 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 training courses in timely manner.
• 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.
• 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 - 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.

Job Requirements

Knowledge, Skills and Abilities

• 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.
• 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 NPD dossiers of international markets.

Experience

• 15+ years’ progressive experience pharmaceutical industry.
• 10+ years’ regulatory filing experience with exposure to new product registration & compliance activities for Finished Dosage forms.
• Candidate should have knowledge about NPD submission requirement and compilation of dossier for international markets. Expertise in LATAM and EMEA would be an added advantage.

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.