Specialist Regulatory Affairs

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 Title: Senior Regulatory Specialist/ Partner – Nutraceuticals/Nutrition

Minimum Qualification & Experience:

• This is a full time, on site role for Regulatory Affairs Specialist, Nutrition/Nutraceuticals located in Hyderabad.
• Master’s Degree in Food Science/Nutrition or related disciplines and/or Master’s Degree in Pharmaceutical sciences
• Minimum 5-7 years of experience in Nutrition and/or Nutraceuticals Regulatory Affairs for India and other mature and/or emerging markets.
• Thorough knowledge of licensing, handling technical queries/deficiencies from regulatory authority (FSSAI), post preparation and submission of dossiers, non-specified food approvals and regulatory updates
• Experience in interaction with health authorities, regulatory influencers and key stakeholders in regulatory and government
• Experience of working in inter-cultural and cross functional teams is a must
• Experience in Pharmaceutical Regulatory affairs is a plus

Reporting: Head Regulatory, (Nutrition/Nutraceuticals).

Key Job Responsibilities:

Regulatory strategy / Dossiers submission, risk assessment and product life cycle management

• In depth understanding of regulatory framework and requirements in India and emerging countries/regions/markets (ROW, CIS, ASEAN)
• Ensure total regulatory compliance of products
• Ensure regulatory compliance for all category of products (Standardized foods, Proprietary foods, Food additives, Food Ingredients, Probiotics, FSDU, Health supplements, Nutraceuticals, etc) with respect to Food safety and standards Act, Food Safety and Standards & Legal Metrology Act, regulations and rules
• Project Management- Ensure product filings are executed as per agreed timelines in continuous collaboration with cross functional teams. Ability to analyse, organize, prioritize and manage multiple projects
• Effective interpretation and monitoring of Nutraceutical existing and upcoming regulatory guidance(s)

Stakeholder Management (Internal and external)

• Interact, contribute and collaborate with all the cross function teams (R&D, NPD, Sales and Marketing etc) to ensure compliance as well as risk assessment analysis of shortlisted or launched products
• Work closely with relevant stakeholders to obtain significant information as well as answer queries that may arise to ensure timely submissions to the relevant regulatory authority
• Support the maintenance of regulatory files to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
• Ensure that all business and technical agreements are evaluated with respect to Regulatory Compliance

Critical Skills Required:

• Clear understanding and minimum 4-5 years of experience in obtaining, maintaining licenses in India (FSSAI- Licensing and Registration Regulation)
• Complete knowledge of dossier submission requirements and specifically should have 2-3 years of experience in filing Non-Specified Food applications in India
• Able to work with cross functional internal and external stakeholders
• Excellent written and oral communication skills
• Open to learning new ways of working

Critical Skills Required:

• Clear understanding and minimum 4-5 years of experience in obtaining, maintaining licenses in India (FSSAI- Licensing and Registration Regulation)
• Complete knowledge of dossier submission requirements and specifically should have 2-3 years of experience in filing Non-Specified Food applications in India
• Able to work with cross functional internal and external stakeholders
• Excellent written and oral communication skills
• Open to learning new ways of working

About the Department
Emerging Markets
Branded generics is one of our biggest businesses in Emerging market and our branded products are available 48 countries across 5 regions. Our key markets are Russia, China and Brazil. We also have presence in Latin America, Africa, Australia, New Zealand, ASEAN (Association of Southeast Asian Nations), CIS and Romania. We have added 13 new geographies in the last 5 years.
In the last 4 years, our emerging markets business’ growth rate has doubled (June ’22). Our diverse portfolio spans all segments. We are continuously advancing technologies, enhancing efficiency of operations and increasing our portfolio of highest-quality quality products.
With nearly 40 products and 6 mega brands, Russia is a key market. With more than 30 years of operations in the region, as of FY22, we have reported a year-on-year growth of 32%. This was driven by improved existing business performance, launch of new products during the year along with divestment of some non-core brands. 6 key products were ranked among the top 200 bestselling formulation brands, as per IQVIA in its report for the 12-month period ended 31 March, 2022. 5 of our leading products were voted as the ’Product of the Year’ by the consumers – reaffirming the trust that the people of Russia have in them.
We are among the earliest Indian pharma companies to have a business presence in China. We have a representative office that focuses on filings and approvals, including the Group Purchasing Organisation (GPO). Our joint venture entity (Kunshan Rotam Reddy Pharmaceutical Co. Ltd) offers a portfolio of niche and essential products, strengthening our presence in China.
In Latin America we have a strong presence in Brazil and Colombia. In just a little over five years in Brazil, our team has established itself in the region with our diverse portfolio. Our primary focus in Brazil is oncology and institutional. Our team in Colombia was certified as a ‘Great Place to Work’.
Through our comprehensive COVID-19 portfolio, we were able to reach over 5 million patients in low and middle-income countries. With the aim of reaching more and more patients around the world, we are harnessing our deep science capabilities to create a robust portfolio in the region to become the partner of choice.
Our teams in China, Brazil, Colombia and Thailand, Malaysia are a certified great place to work. Our team in Russia is among the top 3 in Head-hunter’s Best Employer Ranking in 2022. These recognitions reaffirm our commitment and efforts to bring science, technology and innovation together to offer affordable medicines and solutions beyond the pill to patients in the region.
As the need, scope and standards of healthcare evolve, we keep track of emerging needs to contribute to patient welfare. After all, Good Health Can’t Wait


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/#!/