Regulatory Associate- Biosimilar combination product

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.

We are seeking a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). This role will be responsible for developing and executing global regulatory strategies for combination product devices, ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities.

5+ years of regulatory affairs experience in biosimilars, biologics, or combination product development.

1. Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations.
2. Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings.
3. Ensure accurate regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance.
4. Work closely with R&D, Quality, Clinical, and Manufacturing teams to align regulatory strategies with product development.
5. Support design verification and validation activities, including human factors engineering (HFE) and risk management.
6. Provide regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications.