Regulatory Affairs Consultant (Biologics/Small Molecules)
Primary Location: India, Bengaluru 求人ID R0000035714 Category Regulatory / ConsultingAbout this Role
- 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).
- 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.
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