Manager - Regulatory Affairs - CRLB - Mumbai
Manager - Regulatory Affairs - CRLB - Mumbai
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Job Description
JOB DESCRIPTION:
MAIN PURPOSE OF ROLE
Summarize the main purpose of the role.
Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.
Ability to execute highly complex or specialized projects.
Adapts precedent and may make significant departures from traditional approaches to develop solutions.
MAIN RESPONSIBILITIES
As the Specialist in the Regulatory Affairs Sub-Function considered as highly experienced and knowledgeable resource within the organization 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
Education Level Major/Field of Study Or Education Level
Associates Degree ( 13 years)
Experience/Background
Experience Experience Details
Minimum 7 years
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 sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Required Experience:
Manager
Employment Type
Full-Time
