Regulatory Affairs Specialist Abbott India Ltd

Specialist - Regulatory Affairs - CRLB

     

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)

     

     

     

Experience Level

Mid Level