Regulatory Affairs Consultant

• 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.