Specialist - Regulatory Affairs - CRLB
Abbott
2 - 5 years
Mumbai
Posted: 02/08/2025
Job Description
JOB DESCRIPTION:
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
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
CRLB Core Lab
LOCATION:
India > Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
About Company
Abbott is a global healthcare company developing medical devices, diagnostic tools, nutritional products, and medicines. It focuses on improving health outcomes across areas like heart disease, diabetes, and infectious diseases, with a strong emphasis on research and innovation.
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