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Associate, Regulatory Operations Data Management

City: Gurugram

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

About the role

As a Regulatory Associate, you’re at the forefront of shaping the synergy between our innovative products and the regulatory framework that guides them. Seeking a meticulous and proactive individual, this role offers you the chance to be the regulatory lead on pivotal projects, honing your communication skills, and nurturing robust partnerships — all while delivering critical tasks that influence our global presence. Your contributions will be impactful and meaningful, as you begin to navigate and influence the regulatory scenery that defines our industry.

Your responsibilities

Support the preparation of Module 1 administrative documents such as cover letters, application forms, notification forms, and comparison tables.
Create submission packages aligned with regulatory strategies for pharmaceuticals, biologics, vaccines, generics, and other regulated products.
Perform quality checks and technical validation of submission packages to ensure compliance with regional Health Authority requirements.
Manage and maintain regulatory information in Regulatory Information Management (RIM) systems and document management repositories.
Create, review, update, and maintain regulatory data, including product registrations, submission records, Health Authority interactions, licenses, commitments, and approval information.
Ensure accuracy, completeness, and consistency of regulatory data across systems, dossiers, and regulatory databases.
Support data migration, data cleanup, governance activities, and process improvements within regulatory systems.
Generate regulatory reports, metrics, dashboards, and submission status updates to support decision-making and compliance tracking.
Track submission milestones, maintain regulatory trackers, and monitor timelines to ensure timely execution of regulatory commitments.
Collaborate with Regulatory Affairs, R&D, Quality, Manufacturing, Clinical, and Supply Chain teams to gather, review, and manage submission-related documentation and data.
Conduct regulatory intelligence activities by monitoring evolving global regulations, submission requirements, and industry trends.
Support post-approval lifecycle management activities, including variations, renewals, annual reports, registrations, and product maintenance.
Utilize regulatory publishing tools, document management systems, and regulatory databases to manage end-to-end submission processes.
Participate in process improvement initiatives, inspections readiness activities, SOP compliance, and knowledge-sharing programs.
Continuously develop expertise in global regulatory requirements, regulatory operations, publishing technologies, and regulatory data management practices.

The experience we're looking for

Minimum 7 years of experience in Regulatory Affairs

The skills for success

Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

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