Specialist, Regulatory Affairs FDF

Centrient Pharmaceuticals Netherlands; Gurugram District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Centrient Pharmaceuticals in India is seeking a Regulatory Affairs professional to join the RA-FDF team. You will contribute to obtaining global approvals for Centrient products and manage lifecycle registrations according to business plans.

Role involves dossier preparation, variation packaging, pharmacovigilance support, CMC data evaluation, and cross-functional coordination with RA managers. Excellent communication in English is essential; Prior experience in generic pharmaceutical regulatory

Qualifications

• Academic degree in Pharmacy, Chemistry or Biomedical field.
• 3–5 years’ experience in regulatory affairs in generic pharmaceutical industry.
• Familiar with global registration procedures and requirements.

Responsibilities

• Collect information and prepare dossiers and variation packages as required.
• Compile and update product dossiers for global and for customers registrations (Both NP and LCM).
• Support in pharmacovigilance activities.
• Assist in evaluation of CMC data for dossiers and variation packages.
• Coordinate responses to questions raised by regulatory authorities during regulatory procedures.
• Create and update product information texts.
• Keep updated knowledge of relevant new/draft legislation/regulation/guidance in the global RA environment.
• Cross functional alignment internally and externally regarding regulatory updates, variations packages, and regulatory procedures.
• Contribute to write and review SOPs related to department.
• Report all regulatory data related to activities to ensure RA workplan and MA databases are up to date.
• Support in MDS compliance and creation.
• Escalating to senior RA staff in case of complex regulatory issues or risks.

Skills

Regulatory affairs

English

Communication

Education

Pharmacy, Chemistry or Biomedical degree

Job description

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.

Key Individual Accountabilities

• Collection of information and preparation of dossiers and variation packages as and when required.
• 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
• Support in activities related to pharmacovigilance
• Support in evaluation of CMC data required to support dossiers and variation packages.
• Assist in the coordination of responses to questions raised by regulatory authorities during regulatory procedures
• Creation and updating of product information texts
• Keeping updated knowledge of relevant new/draftlegislation/regulation/guidance in the global RA environment.
• Cross functional alignment internally and externally in relation to regulatory updates, variations packages, and regulatory procedures.
• Contribute to write and review SOP’s related to department.
• Report all regulatory data related to activities to ensure RA workplan and MA databases are up to date
• Support in MDS compliance and creation
• Escalating to senior RA staff in case of complex regulatory issues or risks including implications.

Key Shared Accountabilities

• Ensure support to RA-FDF team and other disciplines within FDF and Centrient in order to meet objectives
• Execute on performance management and act accordingly
• Compliance for FDF

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

Truly global work environment.

High performance culture.

Ability to make a difference.

Best in class compensation.