Around 4-7 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).
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.
