Regulatory Affairs Executive

5 days ago

Gota Ahmedabad Gujarat, India BKM Health Pvt Ltd Full time

(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval 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, Veeva Vault RIM

**Job Responsibility**
- Prepare, compile, and review CTD/eCTD dossiers for submissions (e.g., ANDA /NDA /MAA).
- Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.
- 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, labeling 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.
- 5-10 years of relevant experience in Regulatory Affairs for regulated markets (US/EU)
- In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks.
- Strong understanding of dossier structure, eCTD publishing, and submission timelines.

Pay: ₹40,000.00 - ₹80,000.00 per month

**Benefits**:

- Paid sick time
- Paid time off

Schedule:

- UK shift

Ability to commute/relocate:

- Gota, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

Application Question(s):

- Are you comfortable with UK shift (2pm to 11pm)

**Experience**:

- Regulatory Affairs: 5 years (required)

**Location**:

- Gota, Ahmedabad, Gujarat (required)

Work Location: In person

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