Manager - New Product Development International

APOTEX; Mumbai; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Apotex seeks a senior Regulatory Affairs leader in Mumbai to oversee international dossier submissions, due diligence, and pre-launch variations across LATAM, APAC, EMEA and other markets.

You will coach and manage a regulatory team, coordinate closely with R&D, Quality, Operations and Regulatory Market Affiliates, ensuring compliant processes and timely product launches on a global scale.

Qualifications

• Graduate/Post graduate degree in Pharmacy.
• Detailed knowledge of global regulatory requirements.
• Excellent English communication and leadership.
• Experience supervising regulatory teams in multinational settings.
• 15+ years in pharma with 10+ years in regulatory filing.

Responsibilities

• Schedule and delegate Regulatory Affairs projects.
• Review, compile and dispatch new product submissions and pre-launch variations.
• Handle deficiencies from authorities and ensure timely responses.
• Ensure high-quality regulatory documents meeting one-cycle reviews.
• Coordinate with Affiliates, stakeholders and cross-functional teams.

Skills

Regulatory leadership

Global regulatory

Project management

English communication

Team supervision

Education

Pharmacy degree

Tools

MS Office

Job description

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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.

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

• Education
  • A Graduate/ Post graduate degree in Pharmacy.
• Knowledge, Skills and Abilities
  • Must possess detailed knowledge of the technical, quality compliance, and global regulatory requirements.
  • Excellent oral/written communication in English.
  • 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.