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- Directing the development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
- Interacting with regulatory agencies to expedite approval of pending registrations.
- Serving as a regulatory liaison throughout the product lifecycle.
- Participating in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Regulatory Affairs Manager - Mumbai - Abbott

Description
At Abbott, we are seeking an experienced professional to join our team in the Regulatory Affairs Sub-Function.
This individual will be responsible for applying subject matter knowledge in the area of Regulatory Affairs, utilizing skills and expertise within the context of specific needs or requirements.
The successful candidate will possess well-developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Key Responsibilities:
The ideal candidate will ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products. Additionally, they will serve as a regulatory representative to marketing, research teams and regulatory agencies, providing guidance on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
This role requires an Associate Degree, equivalent to 13 years of education.
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