Specialist, Regulatory Affairs FDF
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Before you apply
LocationGurugram, Haryana, India
Typefull-time
SeniorityMid
Experience3–5 yrs
DepartmentRegulatory Affairs
Company size1,001–5,000 people
PostedJan 8, 2025 · 1y ago
Verified live1d ago
May no longer be actively hiring
Posted by the company on Jan 8, 202541% of this company's open roles have been listed for 90+ days
At a glanceSummarised by Seekless from the posting.
Academic degree in Pharmacy, Chemistry or Biomedical field
At least 3-5 years’ experience in regulatory affairs and/or relevant health registration environments of medicinal products, preferably in the generic pharmaceutical industry
Familiar with the registration procedures and requirements in the global environment
Having followed a wide range of professional training in Regulatory affairs field
Accuracy, creativity, trouble-shooting capability
Good communicator (open minded, transparent), good command of English
About the role
Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are: obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.
Responsibilities
Key Individual Accountabilities
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Collection of information and preparation of dossiers and variation packages as and when required.
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Compilation and update of the product dossiers in portfolio for global and for customers registrations (Both NP and LCM) under guidance from Portfolio Lead and RA managers
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Support in activities related to pharmacovigilance
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Support in evaluation of CMC data required to support dossiers and variation packages.
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Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures
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Creation and updating of product information texts
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Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global RA environment.
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Cross functional alignment internally and externally in relation to regulatory updates, variations packages, and regulatory procedures.
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Contribute to write and review SOP’s related to department.
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Report all regulatory data related to activities to ensure RA workplan and MA databases are up to date
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Support in MDS compliance and creation
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Escalating to senior RA staff in case of complex regulatory issues or risks including implications.
Key Shared Accountabilities
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Ensure support to RA-FDF team and other disciplines within FDF and Centrient in order to meet objectives
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Execute on performance management and act accordingly
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Compliance for FDF
Requirements
Academic degree in Pharmacy, Chemistry or Biomedical field.
•
Having at least 3-5 years’ experience in regulatory affairs and/or relevant health registration environments of medicinal products, preferably in the generic pharmaceutical industry.
•
Being familiar with the registration procedures and requirements in the global environment.
•
Having followed a wide range of professional training in Regulatory affairs field.
•
Accuracy, creativity, trouble-shooting capability.
•
Good communicator (open minded, transparent), good command of English
Benefits
Truly global work environment.
High performance culture.
Ability to make a difference.
Best in class compensation.
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