Regulatory Affairs Executive

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: ₹30,000.00 - ₹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