4 Regulatory Associate Jobs

We are Reckitt Home to the worlds 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, were 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 youll 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 - Collaborate with the team while taking on independent responsibility for regulatory innovation and compliance activities. - Interpret and implement regulations and guidelines as needed to foster industry compliance. - Engage with trade associations, contributing to and utilising our resources to influence favourable legislation. - Understand the regulatory necessities of diverse projects, actively participate in them, and remain alert to project advancements and their benefits. - Manage updates and actions in your area, ensuring tasks are completed effectively and efficiently. The experience were looking for - Proven track record with at least 3 years in regulatory affairs, showcasing full proficiency in this roles requirements. - Proficient in multitasking, executing tasks under pressure, and making objective decisions when faced with complex issues. - Acute business acumen accompanied by commercial awareness. - Demonstrated ability to cultivate insights from consumer interactions and translate them into strategic actions. - Skilled in collaborating with teams across various functions, fostering an environment of partnership building. - Agility to adapt to the ever-evolving technological landscape, complemented by a mindset that seeks to improve and advance current processes. - Experience with product lifecycle management, intellectual property, and innovative workflows. 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 Reckitts 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 Reckitts pay for performance philosophy. We recognise that in real life, great people dont always tick all the boxes. Thats why we hire for potential as well as experience. Even if you dont 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.

Title: Regulatory Associate Date: 8 Jul 2025 Location: Bangalore, KA, IN Job Description We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.comLooking to jump-start your careerWe understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene s high-speed growth.We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have Job Summary: The Scientific and Medical content teams work on different projects across the product life-cycle from regulatory, safety, medical affairs and commercial solutions for our clients. The team leverages the clinical and scientific knowledge and applies to various business problems to reach to various target audiences like the physicians, patients across different therapy areas. In light of this, the role holder in Content Solutions would get an opportunity to learn and partner with healthcare clients on various projects.The Job entails the following but not limited to: Develop, review and edit scientific and medical content meeting International Quality Standards and client organization guidelines for any of the capability belowo Regulatory, Safety, Medical Affairso Medico-marketing, training and Continuous Medical Education (CME)o Commercial Campaigns, digital marketing channelso Content data set preparation, annotation and curationDevelop and prepare content based on target audience (physicians, patients etc.) and mode of deployment (print, web, multi-channels) within short span of time for multiple deliverables Deliver and be able to review content that is rated high on depth, comprehensiveness, quality and timelines within a short span of time Interact with team members to blend the content with creative, technology for projects based on the client needs Interact and defend content based on scientific evidence and facts Demonstrate passion to learn and write for different therapy areas and markets with strong written and verbal communication / presentation skills Be up-to-date with the latest technical /scientific / regulatory developments and applying the learnings on various projects Ability to manage a team within short period of time Good to have EQUAL OPPORTUNITY

Compilation , review of dossier for US , EU , AU, Canada & IL market for both solid oral and non-oral dosage form Review of query response prepared and compiled by regulatory associates Manage all the activities pertaining to dossier submission for aforesaid markets . Meet the dossier submission and query response timeline as per given target Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities Lifecycle management for US , EU , Canada & IL market Single point contacts for all the regulatory submission activities for IL and Palestine markets

Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like - US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. Maintain life-cycle / post approval changes for drug product registration dossiers. Provide regulatory support to cross functional departments. Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway Review, preparation and submission of annual reports to US FDA Review, preparation and submission of post approval supplements to US FDA Reviewing of the plant change control and established the variation strategy for submission Review of query response prepared and compiled by regulatory associates Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities