Manager - Regulatory Affairs

Lupin Limited is seeking a knowledgeable and detail-oriented Manager – Regulatory Affairs to manage regulatory activities for prescription and OTC products, ensuring compliance with TGA, Medsafe, and other applicable regulatory requirements. The involves dossier management, lifecycle maintenance, regulatory submissions, stakeholder coordination, and ensuring uninterrupted product supply through effective regulatory strategies.

Roles & Responsibilities

• Manage and update Product Information (PI) and Consumer Medicine Information (CMI) in line with innovator documents and regulatory timelines.
• Ensure timely reporting of medicine shortages to regulatory authorities such as TGA as per legislative requirements.
• Support compilation and submission of new generic dossiers to TGA and Medsafe.
• Prepare and respond to regulatory queries, deficiency letters, and agency communications.
• Execute labeling updates and regulatory activities to ensure continued product compliance and supply.
• Compile and submit post-approval variations, renewals, and GMP clearance applications.
• Publish dossiers and variations in NeeS and/or eCTD formats as per regulatory requirements.
• Maintain and update internal and external regulatory databases and tracking systems.
• Ensure accuracy, completeness, and timeliness of all regulatory documentation and submissions.
• Process regulatory-related invoices and coordinate with finance teams as per internal procedures.
• Assist in preparation and submission of Risk Management Plans (RMPs) for applicable markets.
• Liaise with external consultants and regulatory partners for outsourced activities.
• Review and assess change controls from manufacturing sites as per regulatory guidelines.
• Provide regulatory impact assessments for product, process, and site changes.
• Stay updated with evolving regulatory requirements, guidelines, and legislation in ANZ markets.
• Share regulatory intelligence and updates with internal teams and stakeholders.
• Provide regulatory guidance to cross-functional teams including QA, supply chain, marketing, and commercial teams.
• Support preparation of regulatory reports and risk assessments related to GMP compliance.
• Assist in managing regulatory risks to ensure uninterrupted product supply in Australia and New Zealand.
• Coordinate with global and local stakeholders for alignment on regulatory strategies.
• Ensure compliance with company policies, regulatory standards, and data integrity requirements.
• Participate in audits and inspections, ensuring audit readiness and documentation availability.
• Drive continuous improvement in regulatory processes and submission quality.

Who We Are

We are a global pharmaceutical company committed to delivering high-quality, affordable healthcare solutions. Our work spans across:

• Generics
• Specialty medicines
• Biosimilars
• Advanced healthcare solutions

With a presence in 100+ markets, we are driven by innovation, quality, and a patient-first approach.

Our Journey

Founded in 1968 by Desh Bandhu Gupta, Lupin began with a simple belief: Quality healthcare should be accessible to all.

From a small venture, we have grown into a global pharmaceutical leader, impacting millions of lives worldwide.

Our Purpose

“We catalyze treatments that transform hope into healing.”

We focus on:

• Improving patient lives
• Driving sustainable growth
• Creating long-term value for stakeholders

Our Core Values

Our values guide everything we do:

• Integrity – Doing the right thing always
• Passion for Excellence – Striving for the best
• Teamwork – Growing together
• Entrepreneurial Spirit – Thinking beyond boundaries
• Respect & Care – Valuing people
• Customer Focus – Putting patients first

‍Patient-Centric Approach

Patients are at the heart of our decisions. We aim to deliver:

• Safe and effective medicines
• High-quality healthcare solutions
• Meaningful patient experiences

Innovation & Science

Our strength lies in:

• Advanced R&D capabilities
• Digital transformation initiatives
• Continuous innovation in healthcare

Manufacturing Excellence

We ensure:

• World-class manufacturing facilities
• Strong supply chain systems
• Strict global quality standards

Global Presence

• 24,000+ employees
• Presence across 11 countries & 6 continents
• A diverse and collaborative global workforce

Quality & Recognition

Quality is embedded in every step—from research to delivery. Our commitment has earned us multiple awards and recognitions globally.

Work Culture at Lupin

We offer a workplace that encourages:

• Growth and learning
• Innovation and creativity
• Collaboration and empowerment

A perfect blend of large-company systems with startup-like agility

Why Join Us?

At Lupin, you don’t just build a career—you make an impact.

• Work on real-world healthcare challenges
• Grow in a purpose-driven environment
• Contribute to improving lives globally