Aurobindo Pharma Limited is looking for Pharma candidates for the post of “Sr Associate/ Team Lead/ Assistant Manager”.
AUROBINDO PHARMA LTD’ (APL). APL is a growing Indian multinational pharmaceutical manufacturing firm with a turnover of over US$2.8 Billion in revenues for 2018-19, with a presence in more than 34 countries fronted presence with products exported to 155 nations. APL is the 2nd Largest Generic Company as per Rx dispensed in the USA.APL is Amongst Top 10 Generic players in France, Germany, Portugal, UK, Italy, Czech Republic, Netherlands & Belgium. APL manufactured 33 Billion+ diverse dosage forms in 2018-19. APL has 27 manufacturing facilities and 5 R&D centers worldwide.
Title: CCDS Report writing – Sr Associate/ Team Lead/ Assistant Manager
Qualification: M. Pharmacy (Pharmacology)
Experience: Experience in Signal Management, Global Label Development, CCDS, USPI and SmPC
Salary: ₹ 5,00,000 – 8,00,000 P.A.
- Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) for CCDS, USPI, and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for high or medium complex projects in the Development and Lifecycle Management (LCM) projects
- Serves as primary contact for cross-functional Labeling Team Member (CFLT), eg Global Regulatory Team Lead (GRTL), Medical Surveillance Team Lead (MSTL), Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally
- Coordinates labeling activities of multifunctional contributors, reviewers, and approvers and manages the label review and approval process to maximize speed and quality
- Ensures effective planning of all cross-functional labeling activities
- Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities
- Reviews country labels to ensure labeling compliance
- Train and provide guidance for other Global Labeling Leads as needed
- Participates in / Leads key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals
- Identifies opportunities to influence regulatory policy and climate with respect to labeling content