Specialist, Regulatory Affairs FDF

Centrient Pharmaceuticals; Gurugram District; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Truly global work environment

High performance culture

Best in class compensation

Job summary

Centrient Pharmaceuticals is seeking a Regulatory Affairs specialist in Gurugram, India. The role involves supporting the RA-FDF team in global product approvals and managing registration dossiers. Candidates should have an academic degree in Pharmacy, Chemistry, or Biomedical field and 3-5 years of experience in regulatory affairs, along with strong communication skills and attention to detail. The position offers a truly global work environment and competitive compensation.

Qualifications

• At least 3-5 years' experience in regulatory affairs and health registration.
• Familiarity with registration procedures in the global environment.
• Professional training in Regulatory affairs.

Responsibilities

• Collection of information for dossiers and variation packages.
• Compilation of product dossiers for global registrations.
• Support in pharmaco-vigilance activities.

Skills

Regulatory affairs experience

Good communicator

Attention to detail

Problem-solving

Education

Academic degree in Pharmacy, Chemistry or Biomedical field

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/draft legislation/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 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 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

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