Regulatory Affairs Executive

1 day ago

Ahmedabad, Gujarat, India BKM Healthcare Pvt. Ltd. Full time

About us:

(BKM) We are seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approved from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, and Veeva Vault RIM

Job Responsibility:

  • Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS).
  • Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.
  • Submit applications to the US FDA, HC, EMA, and other authorities in compliance with regional requirements.
  • Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent.
  • Ensure completeness and technical accuracy of eCTD sequences.
  • Troubleshoot validation issues before final submission.
  • Prepare and manage post-approval changes (CMC variations, labelling updates, packaging changes).
  • Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA's PAS, EMA's Type IA/IB/II).
  • Collaborate with internal departments to gather data and draft scientifically sound responses.
  • Stay updated with changes in FDA, EMA, and ICH guidelines.
  • Maintain regulatory databases, submission trackers, and approval records.
  • Participate in audits and support regulatory inspections.

Required Qualification & Skills:

  • Bachelor's / Master's degree in Pharmacy or related field.
  • 2-5 years of relevant experience in Regulatory Affairs for regulated markets (Health Canada/US/EU)
  • In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks.
  • Strong understanding of dossier structure, eCTD publishing, and submission timelines.

Job Types: Full-time, Permanent

Pay: ₹30, ₹50,000.00 per month

Benefits:

  • Cell phone reimbursement

Ability to commute/relocate:

  • Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Master's (Required)

Experience:

  • FDA regulations: 2 years (Required)
  • Regulatory reporting: 2 years (Required)

Shift availability:

  • Night Shift (Required)
  • Overnight Shift (Required)

Work Location: In person

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