Team Lead - Regulatory Ops-GPR

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.

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Roles & Responsibilities

• Preparation of country specific dossiers and CTD module writing.
• Preparation of various (CTA/MAA/BLA) applications 
• Preparation of query responses for HA submission
• Collaborate with SMEs to address queries from HA
• Effective interactions and collaboration with partner/Affiliate for regulatory filings
• Regulatory review of relevant documents
• Provide support during inspections
• Support in maintaining regulatory systems and databases.

Educational Qualification

Masters/PhD in life sciences

Minimum Work Experience

 8=12 years of experience in Regulatory

Behavioural Skills

• Strong collaborator and excellent communication.
• Good at building and leveraging relationships.
• Adaptability and change management skills.
• Creative and good analytical thinker.

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About the Department: Global Generics India

Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organization with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy, and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations, and inorganic opportunities to become the top 5 companies in the Indian Pharma Market.

" 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/#!/.

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