Dr. Reddy’s Laboratories Ltd. stands as a beacon of excellence in the global pharmaceutical sector, dedicated to accelerating access to affordable and innovative medicines. Founded in 1984, the company began its journey with a modest team of 20 employees and a vision that now spans across 66 countries with over 24,000 employees worldwide. Our commitment to ensuring that “Good Health Can’t Wait” is not just a slogan; it is the driving force behind every endeavor we undertake.

Over the past four decades, we have championed accessibility, affordability, and innovation, underpinned by rigorous scientific research and ethical corporate governance. As the pharmaceutical landscape evolves, we embrace the challenge of strengthening our core business while introducing new innovations. Our mission, “The Next and the New,” reflects our aspiration to be the partner of choice, dedicated to sustainability and patient care, with goals set to reach over 1.5 billion patients globally by 2030.

Work Environment and Diversity Commitment

At Dr. Reddy’s, we pride ourselves on fostering a work environment that promotes diversity and inclusion. We are an equal opportunity employer, dedicated to hiring and nurturing a diverse workforce without discrimination based on race, gender, sexual orientation, disability, or any other protected characteristic. We believe that every employee brings unique talents that contribute to our success, and we are committed to recognizing and valuing this diversity.

Position Overview: Team Lead in Global Regulatory Affairs – API

Job Summary: A Dynamic Leadership Role

We are on the lookout for an experienced and motivated Team Lead in our Global Regulatory Affairs (API) team. The ideal candidate will play a pivotal role in guiding and supporting the regulatory affairs team in their endeavors, offering insights on product and region-specific regulatory requirements. The responsibilities will include providing regulatory support to customers, ensuring timely and accurate submissions, and effectively responding to regulatory agency deficiencies.

Key Responsibilities: Defining the Future of Regulatory Affairs

• Regulatory Guidance: Define regulatory requirements for Drug Master File (DMF) starting materials and suppliers. Collaborate with teams to establish specifications for raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs).
• Product Development: Actively participate in discussions concerning new product development, engaging in phase gate meetings with cross-functional teams to ensure compliance with global regulations.
• Global Filings: Oversee the execution of global regulatory filings, ensuring alignment with established plans and monitoring the progress of DMF preparation. Formulate strategies for submissions, liaising with regional contacts for timely execution.
• Compliance Oversight: Ensure that DMFs comply with international regulatory standards from countries such as Brazil, China, Japan, Europe, and Canada. Address any gaps identified within stipulated timeframes.
• Lifecycle Management: Schedule and oversee lifecycle management activities to ensure compliance with regional requirements, supporting programs for continuous improvement and vendor development.
• Knowledge Sharing and Training: Foster an environment of knowledge sharing within the team through training sessions on evolving regulatory requirements, ensuring that team members remain informed and capable of adapting to changes.

Qualifications: What You Bring to the Table

• Educational Background: A postgraduate degree in Organic Chemistry or Pharmaceutical Sciences is required.
• Experience: A minimum of 10-12 years in API Regulatory Affairs with a solid understanding of Good Manufacturing Practices (GMP) and quality systems.
• Technical Skills: Familiarity with global regulatory requirements, particularly for geographical markets like GDUFA countries, is essential. Understanding pharmaceutical product value chains and intellectual property management will also be beneficial.
• Behavioral Skills: Strong communication, leadership, analytical, problem-solving, and decision-making skills are crucial for this position.

Why Dr. Reddy’s? A Commitment to Growth and Well-being

At Dr. Reddy’s, we prioritize your professional journey. Our commitment to continuous learning is embodied in personalized development programs designed to enhance your career trajectory. Our competitive benefits package encompasses:

• Comprehensive medical coverage for you and your family
• Support for relocation and family care, including maternity and paternity benefits
• Opportunities for continuous learning and advancement

Our Culture: Empathy, Teamwork, and Innovation

Every day at Dr. Reddy’s embodies our motto “Good Health Can’t Wait.” We approach healthcare not just scientifically, but as a mission to empower patients to live healthier lives. Our culture promotes dynamism and empathy, recognizing that diverse skills and collective efforts lead to meaningful impacts.

In joining our team, you will become part of an organization that champions success through collaboration and shared values. We believe that by creating an inclusive and empowering environment, our employees can thrive both individually and as part of a unified purpose.

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