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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/A

In 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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