Job title: Manager Regulatory Affairs (South-Asia Market)
Company: Antal International
Job description: Job Description * Job Title: Manager Regulatory Affairs (French MNC) * Location: Mumbai * Experience required: 5-8 years of experience Experience in Pharma industry primarily quality assurance or pharmacovigilance is favourable. * Educati
Job Description Job Title: Manager Regulatory Affairs (French MNC) Location: Mumbai Experience required: 5-8 years of experience Experience in Pharma industry primarily quality assurance or pharmacovigilance is favourable. Educational requirements: Pharmacist or related academic background is preferred Reporting to: Country Head- GM (India) Major KRA’s include the following: Manage the tasks for regulatory affairs, pharmacovigilance and promotional material review on regulatory perspective and support the quality assurance matters. To give quarterly feedbacks & updates about Policies related to DCGI / CDSCO and other regulatory authorities in India & other territories. Drive drug & medical device registrations and variations in accordance with relevant regulations and develop the strategy to obtain the product approval within target timeframe. Register and keep maintenance of production sites abroad. Mixed Background of Pharma/Medical devices/Pharmacovigilance/Quality is also preferred. Responsible for Pharmacovigilance including reporting / communication with HQ and authorities. Includes being having a role of LRPPV ( local responsible person of pharmacovigilance).
Expected salary:
Location: India
Job date: Fri, 20 May 2022 22:51:46 GMT
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