Opportunity for Senior Regulatory Associate at Indegene- Apply before 30th August 2024

About Indegene

Indegene is a company that aims to revolutionize the healthcare industry through a combination of deep medical and  scientific knowledge, cutting-edge technology, and innovative thinking. At Indegene, teams work on groundbreaking projects, pushing the boundaries of what’s possible, and striving to modernize an industry that has traditionally followed conventional practices. It’s clear that Indegene is committed to challenging the status quo and making a significant impact on healthcare.

Job Title: Senior Regulatory Associate

Role Purpose

As a Senior Regulatory Associate, you will play a crucial role in preparing and managing regulatory dossiers, coordinating with regulatory authorities across EU and ASEAN markets, and guiding internal teams on compliance requirements. Your expertise will contribute to the successful registration and maintenance of our products in these regions.

Key Responsibilities

• Regulatory Knowledge: Demonstrate thorough understanding of EU and ASEAN regulatory requirements, including procedures for initial submissions, licensing, and post-approval management.
• Global Submissions: Manage global regulatory submission formats and oversee submission publishing activities.
• Cross-Functional Collaboration: Lead and participate in cross-functional meetings to facilitate regulatory processes.
• Regulatory Framework: Stay updated on regional trends for small and large molecule applications across the EU and ASEAN markets.
• Submission Preparation: Lead the planning, authoring, and delivery of regulatory submissions, ensuring compliance with global and regional standards.
• Document Management: Utilize regulatory document management systems and publishing tools for dossier preparation.
• Module 1 Documentation: Prepare and support submission of Module 1 documents, including forms, cover letters, and comparison tables.
• Best Practices: Implement and share best practices in regulatory applications and health authority interactions.
• Content Review: Validate and review content prepared by junior team members, ensuring accuracy and quality.
• Team Coordination: Work closely with R&D, quality assurance, and manufacturing teams to gather necessary documentation for dossiers.
• Submission Tracking: Maintain submission trackers and coordinate publishing activities with the relevant teams.
• Risk Management: Identify regulatory risks and propose mitigation strategies to lead and cross-functional teams.
• Health Authority Communication: Ensure clear and timely communication of submissions and requests to global colleagues.
• Regulatory Intelligence: Extract and utilize regulatory intelligence for product registrations across various categories.
• Mentorship: Provide coaching, mentoring, and knowledge-sharing within the regulatory organization.
• Project Flexibility: Exhibit adaptability in managing multiple projects and document types.
• Continuous Learning: Enhance knowledge of writing guidelines and regulatory deliverables through ongoing assignments and training.

Additional Information

• Education: BPharm / MPharm / Pharm.D / MSc
• Experience: 4-6 years in EU/ASEAN regulatory markets
• Location: Bangalore, Hyderabad (Office-based/Hybrid)
• Industry: Pharma / Healthcare / Clinical Research
• Application Deadline: 30th August 2024

Join our team and help us drive innovation in healthcare by ensuring our products meet global regulatory standards.

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