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Senior Executive - Regulatory Affairs

Senior Executive - Regulatory Affairs

Abiomed

2 - 6 years

6 - 10 Lacs

mumbai

Posted:1 day ago| Platform:

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Skills Required

administration business writing data reporting analytical packaging regulatory compliance healthcare licensing regulatory affairs senior executive regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Timely submission of registration application and subsequent query responses.
Make local administrative documents as necessary for submission, draft artwork manuscripts for new products, complete LLD process when required.
Liase with global team & local SC team to arrange required FP samples & reference standards required for testing at Governments labs as a part of registration
Responsible for timely renewals and CMC variations
To prepare, draft, collate various applications as necessary as a part of product registration maintenance activity
Asist in all activities pertaining to the clinical trial.
Responsible for maintaining required internal and external compliance standards.
Cross functional collaborations (eg. MAF, SC) to support respective business objectives.
Supporting packaging material specs creation and Artwork development, assisting SME in this area as necessary.
Any other responsibilities assigned by the manager as per available resources.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

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Senior Executive - Regulatory Affairs