Job
Description
UpMan Placements is inviting applications for an exciting career opportunity with one of our esteemed clients from the Pharmaceuticals industry. Role : Senior Manager RA Location : Nagpur / Mumbai Reporting To : Director BD Role Requirement: Regular interaction and close co-operation with R&D, BD, Production and Logistics Responsible for the dossier filling & query responses of EU, Brazil, Canada & Row market Role Responsibilities: Develop and execute regulatory strategies to ensure timely product approvals. Preparation, review & submission of ECTD/CTD dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products Documents review QQF, Change control, specifications, Commercial specifications, artworks Process Validation Protocols & Report, Hold time study protocol & report, NDMA reports, Photo stability reports, Elemental reports, Risk assessment, Out of Specification. Co-ordination with external & internal clients. Updation and maintenance of database of dossier status. Fulfil requirement for site registration and GMP clearance/approvals Experience and Background: Bachelors or Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field. 12+ years of experience in regulatory affairs within the pharmaceutical industry. Proven track record of successful regulatory submissions and approvals. Required Skills: Strong knowledge of global regulatory frameworks (FDA, EMA, MHRA, WHO, etc.). Excellent documentation, analytical, and problem-solving skills. Ability to interpret and apply regulatory guidelines and requirements. Effective communication and negotiation skills for interactions with health authorities. Strong project management and leadership abilities. Interested candidates can connect with Vanita at 7861882495 or email at vanita@upman.in
