Lead Regulatory Affairs

Lead Regulatory Affairs

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.

Qualifications

• 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.

• Additional Information

• About the DepartmentIntegrated 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 dosagesOur 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 y