Senior Specialist/Asst Manager RA (IC Role)
Senior Specialist/Asst Manager RA (IC Role)
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Job Description
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
Employment Type
Full Time
