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Regulatory Consultant
2 weeks ago
Position – Regulatory ConsultantCompany InformationWe are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore and Australia, and currently establishing in Europe. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in India and internationally.
We have a young and committed team of GMP and Regulatory Experts. We are inviting applications for the role of Regulatory Consultant and are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm. Role & ResponsibilitiesThe person will be responsible for Regulatory consulting services at the firm.
The responsibilities of this position include, but are not limited to, the following:Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed markets (UK, Australia, EU and US) and Emerging markets
Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPsProviding strategic input to the Management and Partners on regulatory projects
Keep abreast of new developments in regulations across all critical health authorities Experience & Qualifications Regulatory affairs experience in small molecules for a minimum of 3-6 years is mandatory
Must be well versed with ICH CTD guidelines and other regulatory guidelines from developed markets (US, EU, UK etc). Must have hands-on experience in regulatory submissions pertaining to generics/ small molecules (m1-m5 CTD writing for EU, Australia and other markets)CEP/ DMF/ ASMF filing with a good knowledge of EDQM requirements would be advantage. Experience in biologics/ biosimilar filings will be an added benefit.
Computer and technical skills (including eCTD software knowledge) Strong & Flawless communication skills. Accuracy and attention to detail.
