Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.
To collaborate with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc to ensure smooth regulatory submissions process
The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.The role is critical to meet planned Site Ready dates
Xogene combines regulatory expertise with advanced technology to automate complex processes in clinical trial disclosure. As trusted experts with comprehensive knowledge of global regulatory frameworks, we deliver efficient data transformation and regulatory compliance for our clients, streamlining workflows through our AI and agentic networking capabilities. We're committed to leveraging technological solutions to advance clinical trial transparency.
Looking for motivated and detail-oriented candidates to join DDReg Pharma as RA Trainees. This role provides an opportunity for freshers to build their career in the Regulatory Affairs domain while gaining practical exposure to regulatory documentation, submissions, dossier preparation, and regulatory guidelines.
B.Sc. / B.Pharma / D.Pharma. experience as a Medical Representative in a Pharma Company. Divisional Business Manager, Area Business Manager, Field Sales Officer in Oral Care, Pain Management, Orthopedics & General Healthcare, Oral Care / ENT / Oncology, Respiratory and Anti-Infectives, Gynecology
Maintain robust governance for label changes triggered by safety signals, clinical/CMC updates, and regulatory intelligence; ensure harmonized global implementation timelines and traceability.