An opportunity is available for an Officer – Regulatory Affairs (DIN11) under the Regulatory Affairs Department. The role focuses on reviewing CMC documentation, preparing and compiling regulatory dossiers, supporting submissions to Health Authorities (HA) in emerging markets, and coordinating regulatory documentation activities with internal and external teams.
Candidates with strong organizational, communication, documentation review, and problem-solving skills can explore this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Reference Number | RV101 |
| Job Code | JP45 – Officer – Regulatory Affairs (DIN11) |
| Department | Regulatory Affairs (DIN11) |
| Country | India |
| Preferred Joining | Immediate |
| Reporting To | JP33 – Executive – DIN11 – Regulatory Affairs |
Positions
- Officer – Regulatory Affairs (DIN11)
Key Responsibilities
The selected candidate will be responsible for:
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- Reviewing CMC documentation, including CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and labelling documents for regulatory filings in emerging markets.
- Attending pre-submission meetings with Health Authorities and preparing post-meeting packages and minutes.
- Assisting in the preparation of high-quality regulatory dossiers for different markets.
- Conducting adequacy reviews and gap analyses of CTD, Non-CTD, and ACTD technical documentation.
- Coordinating with internal and client teams to close comments and review additional incoming data.
- Reviewing and compiling regulatory dossiers.
- Reviewing deficiencies, shortcomings, and supplements received from Health Authorities and coordinating appropriate responses.
- Maintaining proper records in compliance with internal and client SOPs and data security requirements.
- Coordinating document translation activities before and after regulatory submissions.
- Preparing customized reports based on client objectives.
- Providing regulatory intelligence and market knowledge to support successful applications.
- Supporting effective communication with internal and external stakeholders.
- Maintaining updated knowledge of country-specific regulations and guidelines.
Eligibility / Qualifications
Candidates should demonstrate:
- Reasonable knowledge of emerging markets.
- Willingness to learn country-specific regulatory requirements and guidelines.
- Strong organizational abilities.
- Good interpersonal and communication skills.
Required Skills
- Regulatory documentation review
- CMC documentation
- CTD, Non-CTD, and ACTD dossier knowledge
- Regulatory dossier preparation and compilation
- Adequacy review and gap analysis
- Regulatory submission coordination
- Problem-solving abilities
- Strong written and verbal communication
- Excellent computer skills
- Comfortable working with online office applications
- Ability to work under pressure and meet tight deadlines
- Adaptability and flexibility
- Attention to detail and quality-focused execution
