Regulatory Affairs Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

Key Responsibilities

  • Ensure a thorough understanding of regulatory guidelines for finished product registration.
  • Compile dossiers in accordance with established protocols.
  • Review and compile product dossiers for submission in CTD, ACTD formats.
  • Conduct gap analyses on submitted dossiers and address identified gaps prior to MOH submission.
  • Manage customer and MOH queries efficiently.
  • Oversee the lifecycle management of products.
  • Prepare development reports, scale-up reports, specifications, certificates of analysis, stability protocols, and process validation protocols.
  • Review and validate documents including specifications, STPs, analytical method validations, development reports, and validation reports, BMRs, BPRs, PVP/R, and stability documents.
  • Post-approval experience is required to timely file applicable variations.
  • Stay up-to-date with EAEU, ICH, and EMEA guidelines.
  • Assist with re-registration (renewal) procedures.
  • Maintain administrative records of COPP, Mfg. License, and Import License requirements.

Job Requirements

  • Knowledge of regulatory affairs and associated guidelines.
  • Excellent compilation, review, and analytical skills.
  • Ability to work under pressure and meet deadlines.
  • Strong communication and interpersonal skills.
  • Detail-oriented and organized with a focus on quality.

Benefits

  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.
  • Competitive compensation and benefits package.

Other

  • Registration information management system updates will be required on a regular basis.

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