Specialist Regulatory Affairs
Abbott Diagnostics · Delhi · onsite · Posted 42d ago
Undisclosed13–18 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
MAIN PURPOSE OF 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
- Associates Degree ( 13 years)
Experience/Background
- Minimum 1 year
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Regulatory AffairsChemistryProduct Registrationregulatory operationsSubject MatterResearchMedical DevicesRisk ManagementManufacturingoperationsmarketing
About Abbott Diagnostics
Abbott Diagnostics
Internet
1991
35 years old
Waltham,Massachusetts
United States
₹12.4L PA avg
Avg at Abbott Diagnostics
About
Abbott employees do work that matters as part of a global community dedicated to helping people live better and healthier with our life-changing technologies.
Industries
Internet
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