Specialist Regulatory Affairs

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

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

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