DRA Manager

10.00 to 20.00 Years Panchkula 12 Mar, 2024

Job Location	Panchkula
Education	Not Mentioned
Salary	Rs 7 - 14 Lakh/Yr
Industry	Pharma / Biotech
Functional Area	Bio Tech / R&D / Scientist
EmploymentType	Full-time

Job Description

Coordinate efforts associated with the preparation of regulatory documents or submissions.
Liaise with regulatory agencies/ authorities.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Prepare documentation for getting the approval.
Prepare documentation for new applications of existing/ approved labels.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Coordinate, prepare, or review regulatory submission.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed labeling changes.
Participate in internal or external audits.
Compile and maintain regulatory documentation databases or systems.
Write or update standard operating procedures, work instructions, or policies.

Keyskills :
liasingdrug regulatory affairsregulatory affairs

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DRA Manager

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