Manager Regulatory Affairs | Abbott (EPD) | Mumbai
Job Overview
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Date PostedSeptember 11, 2022
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Location (State / UT)
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Expiration date--
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Experience5 Years, 10 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Main Purpose of Role:
- Summarize the main purpose of the role.
- Experienced professional individual contributor that works under limited supervision.
- Applies subject matter knowledge in the area of Regulatory Affairs.
- Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
Main Responsibilities:
- As an Experienced professional in the Regulatory Affairs Sub-Function, possesses well-developed skills in directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- Interacts with regulatory agencies to expedite approval of pending registration.
- Serves as regulatory liaison throughout the product lifecycle.
- Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
- Ensures timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
- Serves as regulatory representative to marketing, research teams, and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
