Pfizer’s Global Regulatory Affairs team!
Work location: Chennai, Ahmedabad, Mumbai & Vishakhapatnam
Walk-in drive at Bangalore on 21st and 22nd May 2022 (9:00 am to 7:00 pm IST)
Venue: The Oterra Hotel, # 43, Electronic City Phase 1, Hosur Road,Bengaluru-560100, India.
Inviting applications from Regulatory Affairs professionals experienced in New Drug Development and Life-cycle Management (LCM) submissions with various Global Health Authorities, for openings in
To function as Global Regulatory Strategist responsible for developing and executing robust regulatory strategies (including CMC authoring and review) for the assigned products/projects.
Experience: 2-15 Years in Pharmaceutical Regulatory Affairs
function experienced in authoring & review of high quality regulatory submissions (INDs/ IMPDS/ NDAS/ ANDAS/ MAASI Post-approval variations) in Global markets (US, EU, Canada, Anz & RoW) for Sterile injectables, OSDs & other dosage forms for small and large molecules (Biologics/ Biosimilars).
To function as Global Labeling Lead (GLL) with overall accountability for the initial creation and relevant updates to labeling documents, and driving the labeling strategy for the assigned products. This includes, ensuring development and maintenance of CDS, USPL, SPC for products registered in EU and their associated Patient Labeling Documents
Experience: 8-12 years of pharmaceutical labeling experience in
content development and maintenance (CDS, USPI, SPC and other country labels, etc. Perspective from HQ Country office and/or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment) necessary. Experience at the country level important and advantageous
Qualification: Minimum Postgraduate in Pharmacy/Life Sciences