Regulatory Affairs Analyst

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 Description

We are seeking a detail-oriented Regulatory Affairs professional to join our team in Hyderabad, India. In this role, you will play a crucial part in ensuring our organization's compliance with regulatory requirements and supporting the development and maintenance of regulatory strategies.

• Preparing the NDA/Registration application for submission to Emerging Markets, communicating with regulatory agencies, and managing the regulatory review process. Ensuring that the drug is approved for marketing in a timely manner and that it meets the regulatory requirements for commercialization.
• Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies.
• Registration application preparation including administrative documents and GMP audit support for global markets.
• Preparation of gap analysis for the registration in Emerging Markets.
• Review, assessment and establishing & tracking effective change control management coming for regulatory review and approval.
• Work with a team of regulatory affairs experts of various countries to ensure that the NDA is submitted correctly and meets respective regulatory agencies requirements.
• Participate in due diligence activities for innovative pipeline assets, identify necessary clinical and regulatory requirements needed for regulatory approval in Emerging Markets.
• Work closely with Cross-functional teams for review of Normative Document (ND) and ensure timely submission of samples for PQC testing
• Identify and assess regulatory risks, mitigations, opportunities, and contingencies.
• Liaise closely with the CMC and clinical teams to ensure all regulatory requirements are met and all information needed for ongoing documentation and registration is produced.
• Review Clinical trial protocols, Clinical study report contents and approval requirements to facilitate CT NOCs and marketing authorization approval by regulatory agencies
• Ensure effective planning, preparation and timely submission of INDs, CTAs, NDAs, and other regulatory documents and applications, as required
• Provide strategic direction (and content input) on product labelling
• Ensure adherence to and continuous improvement of standards, processes and guidelines for regulatory submissions of innovative products
• End to End RA function support for allocated asset/country: Guide by providing regulatory strategy for complex molecules/asset. Provide functional support to RA and CFT members to meet the current regulatory requirements and guidelines in order to secure the acceptances, approvals and launches of innovative assets.
• Accountable for decisions and appropriateness of submission documentation to support successful NDAs/MAAs/Dossiers and other submissions to various agencies.
• Deficiency Management: Coordinates and Collaborates with multi-disciplinary matrixed teams in relation to pending deficiencies to meet timelines with appropriate prioritization. Guides RA and CFT members by providing appropriate regulatory strategies to ensure the accuracy and adequacy of the response.
• Support the Launch team - Supports the launch team by providing necessary regulatory strategies, inputs and decisions for the proposed changes, if any, within the regulatory framework thus safeguarding the regulatory compliance and the launch of the product.
• Ensures the smooth transition of the approved and launched products to the Life-cycle Management (LCM) Process along with the history of approval process.

Qualifications

• Masters in Pharmacy
• Well-versed with the new drug development process and understanding of scientific content and complexities related to NCEs.
• Thorough understanding of the regulatory agencies requirements of various countries for NDAs/MAAs, including the required format and content of the application.
• Around 5 years of experience in regulatory domain with knowledge of NDAs/MAAs submission to various Health Authorities (HAs) and associated processes.
• Proficient in eCTD requirements and Hands-on experience of submitting registration application in eCTD format to the HAs.
• Fundamentals on the following is necessary:
  • Understanding of Good Manufacturing practice/Quality Systems.
  • Experience in incoming, outgoing and product quality.
  • Knowledge of Intellectual Property Rights.

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered