Senior Specialist/asst Manager Ra

2 days ago

Delhi, India People First Consultants Full time

Position Summary Principal Responsibilities Compile and review regulatory submissions for timely registration of new products on-time renewal of registered products Develop timelines coordinate receipt of technical information from global RA and independently execute new product registrations change reporting and PAC submissions Review technical documents before submission to external party and or Health authority to ensure the documents meet and or fulfil the country requirement request Ensure the documents are legalized and or notarized where required Monitor and update registration activities and or status to all relevant stakeholders on a regular basis Ensure the required actions and responses are in place in a timely manner Demonstrate strong understanding of MDR 2017 and associated regulations LMR DPCO Drugs and Magic remedies Act etc in handling medium to complex from Central State Licensing Authority NPPA Timely assessment of incoming changes to global and keep business aligned on impact if any Oversee India supplementary labeling compliance along-with QA Take lead in project planning budget review and support in managing RAQA KPI metrics Lead cross-functional discussions with Supply chain planning and L D operations team to maintain uninterrupted business continuity Mentoring new team member associates and lending support in acquiring know-how required to work under minimal guidance Provide timely intel to reporting manager in sending out key communication internal document modification to ensure minimal no impact to business Monitor changing new requirements and prepare policies guidelines training for employee to ensure awareness and timely implementation of same Provide support to Institution business team on tender related requests Education The ideal candidate would have a diploma degree in a scientific discipline such as Biology Microbiology Pharmacy pharmacology Biotechnology engineering or medical technology Minimum 5 years of experience in Medical devices regulatory affairs and 7-8 years of working experience in a Medical devices Pharmaceutical company Good working knowledge of MS-EXCEL and PowerPoint will be preferred BEHAVIOUS VALUES Team player having an analytical and problem-solving mindset Highly motivated willing to learn and having an open mindset Must be approachable and have a positive mindset Flexible and adaptable to changing environment and needs Must be a patient listener and have a rational mindset towards solving problems Demonstrate strong integrity in dealing with different external stakeholders

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