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Executive - Regulatory Affairs

Executive - Regulatory Affairs

Abiomed

1 - 4 years

5 - 8 Lacs

mumbai

Posted:Just now| Platform:

Apply

Skills Required

neurology analytical project management healthcare market research licensing regulatory affairs operations software quality assurance proof reading

Work Mode

Work from Office

Job Type

Full Time

Job Description

- Daily updating of the trackers, tracking submitted applications for India, updating team on queries, new notifications received & daily dispatches if any.

- Archival for documents like approvals, query letters etc in appropriate manner

- Sharing NMRA updates.

- Support operational activities for product registrations in India for Communicable Diseases, Metabolics, Neurology and Established Products portfolio- Making complete dossiers and query responses within specified timelines

- Coordinate with global team to arrange required FP samples & reference standards required for testing at Governments labs as a part of registration.

- Support operational activities for lifecycle management Communicable Diseases, Metabolics, Neurology and Established Products portfolio- filing of RC & IL renewals in timely manner to ensure business continuity

- Coordination with Regional Regulatory for Supporting documents required for various applications for submission

- Support with operational activities to other team members as and when required

- Support for sample testing at Government labs or equivalent labs as required

- Maintain database for SEC meeting minutes.

- Back up for ARR related QMS documentation

Required Skills:

Preferred Skills:

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Execution Focus, Market Research, Package and Labeling Regulations, Process Oriented, Product Licensing, Product Packaging Design, Project Management, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Safety-Oriented

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Executive - Regulatory Affairs