• Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets, mainly US and EU.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
• Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
• Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
• Experience in handling CMC related health authority queries, and author responses to HA requests
• Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
• Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
• Â Authoring CMC component for marketed products, of Annual Reports, Variations, Renewals in EU (Type IA/IB/II/IAIN), and US and RoW markets.
• Evaluation of change controls and deviations and identification of required documentation and strategy for EU/US submissions and other markets.
• Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents, as early as possible.
• Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
• Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members.
• Ability to work independently.
• Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
• Authoring content of the drug product label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
• Familiarity with EU Guidelines for QRD / Excipients.
• Artwork management for countries with label in English.