Hiring for Manager / Asst. Manager - Regulatory Affairs | Pharma in Anand, Bharuch for Exp. 5 - 7 yrs at Sudeep Pharma Private Limited.
Vadodara, Gujarat, India
Mar 31, 2019
Job Description:Manage and lead Regulatory Affair Department in handling different regulatory authority requirement. Responsible in preparation, review and approval of complete dossiers as CTD or eCTD to Regulatory Authorities. Authorized to handle Inquiries from Regulatory Authorities related to company and product registration. Submission of Registration Dossiers in US, UK, EU, China, South America, AU , ROW and other international market. To make sure that timelines are met for the project submissions including dossier, query response, variations, reports, renewal procedures, and all other regulatory applications. Confirming the product quality and other requirements to the quality team at the time of production planning and confirming that every requirement related to quality aspects are fulfilled before dispatch. Strategy planning and reviewing for the Regulatory dossier filings. Reviewing all technical documents like DMFs, Stability data and protocol, COAs, process validation, analytical method validation and media fill validation, HVAC validation, SOP, STP/Spec. as per the requirement of the dossier preparation and registration. Involved in Design and approval of product Artwork, Preparing marketing tools (brochure/ literature review and one pagers) for marketing team. Coordinating for Regulatory and Customer Audits as per schedule.