Pfizer Limited was listed on the Indian stock exchange in 1966. Today, the company has over one lac shareholders in India. With annual sales of over Rs. 2,000 crores, it is the fourth largest multinational pharmaceutical company in India. The Company has a portfolio of over 150 products across 15 therapeutic areas. Its top brands include Prevenar 13, Lyrica, Corex – DX, Dolonex, Enbrel, Becosules, Gelusil and Folvite among others. In addition to its commercial operations, Pfizer Limited also operates a state-of-the-art, award-winning manufacturing facility in Goa that produces more than a billion tablets annually.
Vacancy Details
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
Regulatory Strategy:
- 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/ NDAU ANDA MAA 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)
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, 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
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.
