Regulatory Affairs Executive

1 hour ago

Mumbai Maharashtra, India IMPACT LABS PRIVATE LIMITED Full time

**Licensing & Approvals**:

- Obtain product permissions from relevant regulatory authorities.
- Liaise with government agencies to ensure timely approvals and renewals

**Dossier Compilation**:

- Compile, review, and submit regulatory dossiers in **CTD (Common Technical Document)** and **ACTD (ASEAN Common Technical Document)** formats.
- Ensure documentation complies with national and international regulatory standards.
- Coordinate with internal departments to gather required technical and quality data.

**Artwork Compliance**:

- Review product artwork and labeling to ensure alignment with regulatory standards and country-specific requirements.
- Provide feedback and corrections to design teams to maintain compliance.

**Qualifications & Skills**:

- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
- 2-5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry.
- Strong understanding of regulatory guidelines (e.g., CDSCO, ASEAN).
- Proficiency in dossier preparation and submission processes.
- Excellent communication and documentation skills.

**Job Types**: Full-time, Permanent

Pay: ₹180,000.00 - ₹360,000.00 per year

**Benefits**:

- Health insurance

Work Location: In person

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