Consultant, Regulatory Operations

COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here . Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: The Consultant, Regulatory Operations will support the preparation, formatting, compilation, publishing, validation and dispatch of regulatory submissions in accordance with applicable regional requirements, internal procedures and project timelines. This role is responsible for assisting with submission-ready document preparation, eCTD publishing activities, technical validation checks and lifecycle submission support for dossiers such as IND, NDA, ANDA, MAA, variations, renewals, amendments and responses, as applicable. The position requires hands-on support in regulatory document conversion, hyperlinking, bookmarking, PDF quality checks, eCTD sequence preparation, validation using approved tools, and submission dispatch through relevant health authority gateways under the guidance of senior team members. The role also involves coordination with CMC Regulatory Affairs, Labelling, Clinical, Quality and other cross-functional teams to ensure timely collection, organization and processing of documents while maintaining accuracy, compliance and audit-ready documentation standards. WORK LOCATION : Bangalore KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) Prepare, convert, format and quality check regulatory documents, including clinical, nonclinical, CMC, labelling and administrative documents, to ensure they are submission-ready and compliant with applicable formatting standards. Perform document-level activities such as PDF conversion, hyperlinking, bookmarking, pagination checks, document property verification, file naming checks and technical readiness review as per internal procedures and submission requirements. Support compilation and publishing of assigned regulatory submissions in eCTD format using approved publishing tools under the guidance of senior team members. Assist in preparation of regulatory submissions including IND, NDA, ANDA, MAA, variations, renewals, amendments, supplements and responses to health authority queries, as applicable. Perform eCTD sequence preparation, document placement, leaf title checks, metadata review and lifecycle operator c…