Ferring is a research-driven, specialty biopharmaceutical group committed to helping people build healthy families and live better lives. Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.
Post : Manager - Regulatory Affairs & Pharmacovigilance
Job Description
• Compilation and submission of dossier for clinical trial applications, new drug applications, registration applications, renewal applications, post approval change applications and Test licence applications; address queries from the regulators and obtain the approvals in India, Srilanka, Bangladesh, Nepal, Pakistan & Bhutan
• Responsible for creating & updating Regulatory & Pharmacovigilance SOPs, product artworks, prescribing information, Regulatory & Pharmacovigilance database
• Responsible for obtaining documents and certificates for regulatory submission and Tendering process, from various stakeholders & responsible for submission of applications to State FDA
• Co-ordination with Internal stakeholders including Global Regulatory Affairs, production sites, other functions and external partners
• Responsible for monitoring the safety mailbox, data entry of all types of individual case safety reports, safety reporting, maintenance of Pharmacovigilance records and acting as Local Safety Officer
Additional Information
Location : India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs & Pharmacovigilance
End Date : 30th January, 2022
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