Regulatory Affairs Analyst at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

19 Sep, 26

Salary

0.0

Posted On

21 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Lifecycle Management, Regulatory Submissions, EMA Guidelines, CMC Documentation, Variation Preparation, Product Information Updates, Regulatory Compliance, Stakeholder Management, English Communication, MS Excel, Google Applications, Regulatory Strategy

Industry

Pharmaceutical Manufacturing

Description

Company Description Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait. We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Job Description We are looking for a Regulatory Affairs Specialist – Global Lifecycle Management (LCM) to support and manage post‑approval regulatory activities across global markets, ensuring compliance and timely maintenance of product licenses. This role is pivotal in managing activities related to global lifecycle submissions, including variations, renewals, label updates, artwork changes, CMC updates, site transfers, and administrative maintenance. Collaboration with global Health Authorities, manufacturing sites, and internal cross‑functional teams will be essential to ensure continuous regulatory compliance of marketed products. Roles & Responsibilities Should have regulatory experience in lifecycle management activities for multiple markets especially in Europe Preparation, review, and submission of variations (Type IA/IB/II), renewals, notifications, and administrative updates for global markets including EU, UK, and RoW markets etc. You will be responsible for preparation and review of Module 1 and CMC variation documentation You will be responsible for preparation of product information updates (SmPC, PIL, labels) and review of artworks to ensure regulatory compliance. Direct interaction with global regulatory authorities (EU NCAs, MHRA, other countries health authorities officials as applicable). Handling of post‑approval deficiencies/queries and providing timely responses to regulatory agencies. Good interpersonal skills with strong command of English to communicate with regulatory authorities & IL customers/partners. Providing regulatory guidance and regulatory strategies to CMO's and other cross‑functional teams for post‑approval changes. Support manufacturing sites during regulatory audits, inspections, and compliance‑related queries. You will be responsible for monitoring and follow‑up of product lifecycle submissions for early and timely approvals. You will be responsible for updating and maintaining regulatory databases, tracking tools, and submission logs. You will be responsible for participating in industry associations to keep abreast of global post‑approval regulatory requirements. You will be responsible for creation and revision of new or existing SOPs related to lifecycle management. You will be responsible for maintaining strong relationships with global health authorities and regulatory stakeholders. You will be responsible for delivering lifecycle management goals with minimum supervision. You will be responsible for performing other tasks and duties assigned by the immediate supervisor. Qualifications Educational qualification: M.pharm Minimum work experience: 4 plus years of experience in regulatory affairs preferably in Europe Lifecycle management activities Skills & attributes: Knowledge of EMA guidelines. Proficiency in spoken and written English. Proficiency in using a computer and its applications, specifically Google Applications and MS Excel. Excellent interpersonal and communication skills. Attention to detail and the ability to multi-task and meet strict deadlines. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/ Job Family: Regulatory Affairs Sub Job Family: Regulatory Affairs General Preferred type of working: On-Premise Years of Experience: 6 - 12 Business unit: IPDO

Responsibilities

Manage post-approval regulatory activities and global lifecycle submissions, including variations and renewals, to ensure compliance across global markets. Collaborate with health authorities and cross-functional teams to maintain product licenses and update regulatory documentation.