Regulatory Affairs Manager

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 Summary

We are seeking a dynamic, motivated and experienced member in our Regulatory Affairs team. This position will be based at Delhi and the candidate should have at least 8-12 years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, NDCTR, GMP, GCP, DMR, etc. This person will be responsible for handling (reviewing, submitting & follow up) applications pertaining to New Drug, Subsequent New Drugs, FDC, Biological (Vaccine, Biosimilar, CGT), GCT, Medical Device, BE for Export, Written confirmation, Cosmetics, etc. Experience will not be a barrier for the right candidate.

Roles & Responsibilities

• You will be responsible for liaising with Central Drugs Standard Control Organization (CDSCO), Zonal offices as well as State Drugs Offices for necessary Drugs approvals to support markets in India and emerging markets.
• You will be responsible to manage relationships with national regulators at CDSCO/Zonal/State level and other relevant regulatory agencies (IPC,NIB, NPPA, RCGM,etc).
• You will be responsible for reviewing & submitting of applications/portfolio assigned to you and also following up with the CDSCO/Zonal/State Regulators for the same.
• You will be responsible for providing necessary feedback to the Central Regulatory Affairs (RA) team based on day-to-day interactions with regulatory authorities.
• You will be responsible for Handling, reviewing, and approving artworks in compliance with regulatory requirements.
• You will be responsible for Tracking the validity and expiry of licenses and planning for the renewal of licenses and certificates, post approval commitments within regulatory timelines.
• You will be responsible for Supporting the Regulatory Affairs team with the necessary documentation for Drug registration and maintenance 
• You will be responsible to ensure regulatory compliance for the approved products / products under filing and also in case of new regulations.
• You will be responsible for providing regulatory intelligence and keeping track of changing regulatory environment which may impact the organisation.
• You will be responsible for updating and maintaining a centralised Management Information System (MIS) database for all related activities on a daily basis.
• You will be responsible for maintaining the timelines for approvals, submissions, SEC meeting inclusions, etc.
• You will be responsible for developing and implementing regulatory strategies to support product development and lifecycle management.
• You will be responsible for collaborating with cross-functional teams to ensure regulatory compliance throughout the product development process.
• You will be responsible for preparing and reviewing regulatory submissions for clinical trials and marketing authorisations.
• You will be responsible for conducting regulatory risk assessments and developing mitigation strategies.
• You will be responsible for participating in regulatory inspections and audits, ensuring proper preparation and follow-up actions.

Educational qualification: B.Pharma/ M.Pharma/ Life Science Graduate or PG

Minimum work experience: 8-12 years

Skills & attributes:

Technical Skills

• Understanding of Good Manufacturing Practice/Quality Systems, D&C Act, NDCTR, etc.
• Understanding of product development, manufacturing processes, Intellectual Property and quality.
• Knowledge of Indian Regulatory requirements.
• Proficiency in regulatory information management systems and databases.
• Familiarity with international regulatory guidelines (e.g., ICH, WHO).
• Experience in preparing and reviewing regulatory submissions for various product types.
• Knowledge of pharmacovigilance and post-marketing surveillance requirements.

Behavioural Skills

• Excellent communication and interpersonal skills.
• Efficient team player and a good collaborator.
• Good influencing skills.
• Strong analytical and problem-solving abilities.
• Attention to detail and ability to manage multiple projects simultaneously.
• Adaptability to changing regulatory landscapes and organisational priorities.

Additional Requirements

• Proficiency in Microsoft Office suite and regulatory-specific software.
• Willingness to travel for regulatory meetings and inspections.

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/#!/