Require Senior Regulatory Associate at Indegene

We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready.

Post : Senior Regulatory Associate

Job Description
Role Purpose
Candidate will be responsible for preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets and providing guidance on regulatory requirements to internal teams.

Job Description
• Thorough knowledge of EU & ASEAN markets - country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management
• Experience with global regulatory submission formats, including familiarity with submission publishing activities
• Organizes, leads, and facilitates and or participates in cross functional meetings with stakeholders
• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across EU & ASEAN markets
• Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
• Hands-on experience on regulatory document management systems and publishing tools
• Able to support and prepare Module 1 documents - submission form, cover letter, notification forms, comparison tables for regulatory submission
• Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment
• Review the content prepared by junior team members. Validate the authenticity of the content by performing QC of the dossier prepared

• Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation
• Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals.
• Tracking and maintaining the submission trackers
• Identifies regulatory risks and proposes mitigations to Lead and cross functional teams
• Ensure submission/query/additional request by HA should be communicated to the global colleagues through agreed process
• Able to extract regulatory intelligence information (requirements for CTA, drug/device/cosmetic/food registration etc.)
• Provides coaching, mentoring and knowledge sharing within the regulatory organisation
• Mentoring of new joiners with respect to SOPs and processes
• Exhibit flexibility in moving across new projects and preparation of multiple document types
• Continuously enhance and maintain knowledge of various writing guidelines for different deliverables by doing various assignments
• Understand various target audience and methods to approach different deliverables
• Volunteer in training programmes to develop skills in areas relevant to the job in addition to the areas of interest

Additional Information
Education : BPharm / MPharm/ Pharm.D/ MSc
Experience : Required 4-6 years of experience in EU/ASEAN markets
Location : Bangalore, Hyderabad (Office-based/Hybrid)
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th August 2024