Founded in 1849, Pfizer is the worlds premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Inviting applications from Regulatory Affairs professionals experienced in New Drug Development and Life-cycle Management (LCM) submissions with various Global Health Authorities
Regulatory Strategy : To function as Global Regulatory Strategist responsible for developing and executing robust regulatory strategist (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/ MAAs/ Post-approval variations) in Global markets (US, EU, Canada, AnZ & RoW) for Sterile injectables, OSDs & other dosage forms for small and large molecules (Biologies/ Biosimilars).
Labeling : 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, USPI, 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
Work Location : Chennai, Ahmedabad, Mumbai & Vishakhapatnam
Walk-in drive at Hyderabad on 21st and 22nd May 2022 (9:00 am to 7:00 pm 1ST)
Venue : The Oterra Hotel, #43, Electronic City Phase 1, Hosur Road, Bengaluru-560100
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