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I&D Operational Excellence Specialist at Abbott Pediatrics

Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

26 Dec, 25

Salary

0.0

Posted On

27 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Product Registration, Approval Processes, Regulatory Strategy, Risk Management, Chemistry Manufacturing Control, Product Lifecycle Management, Manufacturing Changes, Technical Labeling, Regulatory Liaison, Marketing Collaboration, Experience Reports, Amendments, Supplements, Progress Reports

Industry

Hospitals and Health Care

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 the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. • Interacts with regulatory agency to expedite approval of pending registration. • Serves as regulatory liaison throughout product lifecycle. • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, 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. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Associates Degree (± 13 years) ☐ Experience/Background Experience Experience Details Minimum 1 year

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Responsibilities

The role involves directing the development of product registration submissions and interacting with regulatory agencies to expedite approvals. The specialist serves as a regulatory liaison throughout the product lifecycle and advises teams on compliance with regulations.