Regulatory Affairs Lead - NCE

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 looking an experienced Lead Regulatory Affair to oversee the review of critical documents, ANDA (Abbreviated New Drug Application) submissions, and deficiency responses, ensuring compliance with regulatory guidelines and internal checklists within the Global Regulatory Affairs department for formulations. You will be responsible for preparing regulatory strategy notes, regulatory due diligence and gap analysis for leverage products in consultation with vertical head. Review and closure of change notifications (CRNs) for under development, under review and launch products, providing launch support w.r.t regulatory decisions and provide regulatory guidance/updates to the cross functional teams.

Roles & Responsibilities

>  The ability to develop and execute the regulatory filing & approval strategy by identifying the most appropriate regulatory pathway, assessing approval requirements across different markets, anticipating regulatory risks, and aligning development plans with agency expectations.  skill to of business strategy and priorities, with the ability to align and execute plans according to the established strategy.

• Preparation & filing of orphan drug designation application, priority review applications, rare-disease application with various regulatory agencies based on the product need.

• You will be responsible for dossier finalization, by finalizing scope, initiating projects with relevant stakeholders, planning, monitoring activities, and reviewing content for finalization. You will identify known risks and propose mitigation plans, as well as communicate and align with the overall product positioning in appropriate governance forums.

• You will be responsible for filing and obtaining approval for regulatory applications by ensuring the timely filing, deficiencies management and approval for various studies and authorizations, and providing strategy and positioning information for query responses. Additionally, you will be involved in follow-ups with partners, affiliates, to ensure timely approvals.

• You will be responsible for liaison with partners, cross functional teams, and commercial teams, providing guidance on regulatory requirements and positioning information in dossiers and query responses. This involves participation in program / project / governance forums and reviewing product development plans.

• You will engage in external liaison with partners / affiliates and health agencies to ensure accurate information is shared with regulators. Proactive management and response to query responses within specified turnaround timelines and proper archiving of reference documents for future use are also part of your responsibilities.

• You will be responsible for preparing and reviewing controlled correspondences, briefing books, and meeting packages to obtain clarity on regulatory issues and provide regulatory strategy notes and due diligence for product development.
• You will be responsible for timely identification of open issues and anticipated questions on regulatory submissions, ensuring compliance and avoiding delays in approval.
• You will be responsible for reviewing and closing change notifications (CRNs) for products under development, review, and launch, in consultation with vertical head.
• You will be responsible for Providing launch support by reviewing launch-related documents and ensuring critical points are addressed in consultation with vertical head.
• You will be responsible for interacting with internal and external customers to provide timely regulatory guidance and support for submissions.
• You will be responsible for providing real-time regulatory guidance and updates to partners & cross-functional teams to ensure compliance with current regulatory requirements during product development.

Educational qualification: A Master’s degree in Science or Pharmacy.

Minimum work experience: 10 to 15 years of experience, with 5 years of experience in regulatory affairs in filing and approval of new drugs / NCEs

Skills & attributes:
Technical Skills

• Sound understanding regulatory landscape of various emerging markets with an ability to develop and execute the regulatory filing & approval strategy.  

. Understanding of pharmaceutical development, process validation, analytical method development, stability programs, comparability assessments,

. Understanding of non-clinical and clinical development requirements including interpreting toxicology studies, pharmacokinetic and pharmacodynamic data, bioequivalence studies, comparative efficacy studies, and safety assessments.

• Good negotiation skills, enabling effective communication and collaboration, especially in the context of regulatory affairs.
• Understanding cross-cultural sensitivities, which is crucial in international business environments and regulatory interactions.
• Excellent presentation skills, both oral and written, allowing for effective communication of regulatory information to diverse stakeholders.
• Ability to design and customize IT platforms that support regulatory activities, including but not limited to Electronic Common Technical Document (eCTD), Document Management System (DMS), and Regulatory Information Management System (RIMS).

Behavioural skills
• Demonstrates the ability to identify risks and proactively propose effective mitigation plans.
• Pays meticulous attention to details while maintaining a strategic perspective to address broader business needs.
• Effectively manages and responds to ad hoc priorities that arise due to requests from the Ministry of Health (MOH ).
• Demonstrates a commitment to continuous learning and staying updated on the latest regulatory expectations.
• Demonstrates expertise in effectively leading and coordinating activities across diverse functional teams.

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/#!/