Manager – Regulatory Affairs
Job Location
Mumbai, India
Job Category
Regulatory Affairs
Employment Type
Full-Time
Experience Required
Minimum 10 years of experience in Regulatory Affairs, Research and Development, Manufacturing, or related pharmaceutical industry functions.
Educational Qualification
Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related scientific discipline.
Job Overview
The Manager – Regulatory Affairs is responsible for supporting product registration activities, regulatory compliance, and lifecycle management of pharmaceutical products. This role involves leading regulatory submissions, ensuring compliance with global and regional regulatory standards, and collaborating with cross-functional teams to support regulatory strategies.
The position requires strong expertise in Chemistry, Manufacturing, and Controls (CMC) regulatory processes, health authority interactions, and regulatory documentation management to ensure timely product approvals and ongoing compliance throughout the product lifecycle.
Primary Responsibilities
Product Registrations and Regulatory Submissions
Lead product registration activities by preparing and requesting documentation for complex regulatory filings.
Manage submission timelines using project management methodologies to ensure regulatory deadlines are achieved.
Prepare registration packages for routine submissions and identify required supporting data.
Collaborate with technical experts to address complex regulatory requirements.
Prepare and submit responses to regulatory authority deficiency letters.
Cross-Functional Collaboration and Stakeholder Engagement
Represent Regulatory CMC in project meetings and communicate regulatory positions effectively.
Monitor regulatory project progress against planned timelines and communicate updates to stakeholders.
Identify potential risks impacting regulatory activities and recommend mitigation strategies.
Affiliate Coordination
Maintain strong working relationships with regional product leads and affiliate teams.
Ensure alignment of regulatory activities across global and regional stakeholders.
Lifecycle Compliance Management
Evaluate and approve product change requests and maintain regulatory documentation.
Monitor evolving regulatory legislation and industry developments.
Ensure continuous product compliance with applicable regulatory standards.
Regulatory Strategy Development
Develop and implement regulatory CMC strategies for assigned products and projects.
Identify regulatory risks and implement mitigation plans to support business objectives.
Process Improvement and Documentation
Identify opportunities to improve regulatory processes and operational efficiency.
Support development of regulatory position papers, work aids, and process documentation.
Health Authority Interaction
Participate in regulatory agency meetings and support regulatory communication activities.
Licensing and Due Diligence Support
Provide regulatory CMC expertise for licensing reviews and due diligence activities.
Technical and Regulatory Expertise
Maintain knowledge of scientific and technical principles relevant to assigned products.
Develop expertise in global and regional regulatory frameworks and country-specific requirements.
Core Competencies
Adaptability
Prioritize short-term and long-term regulatory activities effectively.
Adjust timelines and resolve issues in dynamic regulatory environments.
Initiative
Proactively identify challenges and implement solutions.
Continuously develop knowledge of business functions and regulatory processes.
Innovation
Apply creative problem-solving approaches to regulatory challenges.
Integrity and Quality Focus
Deliver high-quality regulatory outputs within agreed timelines.
Demonstrate accountability, transparency, and ethical conduct.
Team Collaboration
Work collaboratively with cross-functional teams to achieve shared objectives.
Leadership Competencies
Define and communicate regulatory strategies to key stakeholders.
Mentor and support junior team members through knowledge sharing and training.
Drive performance and encourage achievement of project goals.
Facilitate effective decision-making through cross-functional collaboration.
Promote open communication and continuous learning within teams.
Role Scope and Reporting Structure
Individual contributor role with no direct or indirect reports.
Operates with a high degree of independence while collaborating with internal and external stakeholders.
Career Opportunity
This role offers an opportunity to contribute to global regulatory strategy, product lifecycle management, and compliance initiatives within the pharmaceutical industry. The position provides exposure to international regulatory frameworks, cross-functional collaboration, and strategic regulatory decision-making processes.
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