14 Nov
|
IMPACT LABS PRIVATE
|
Mumbai
14 Nov
IMPACT LABS PRIVATE
Mumbai
Licensing & Approvals:
- Obtain product permissions from relevant regulatory authorities.
- Prepare and submit applications for current manufacturing licenses.
- 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 Type
s: Full-time, Permanent Pay: ₹180,000.00
- ₹460,000.00 per year
Benefits:
- Health insurance Work
Location:
In person
📌 Regulatory Affairs Executive (Mumbai)
🏢 IMPACT LABS PRIVATE
📍 Mumbai