
Asst. General Manager-Regulatory Affair
H&H Healthcare And Cosmetics Private Limited
Indore, Madhya Pradesh, India
Posted on 01-09-2025
1 Vacancy
Description
- Lead and oversee all regulatory affairs activities, ensuring compliance with national and international regulations.
- Develop, implement, and monitor regulatory strategies for product approvals, variations, and renewals.
- Liaise with regulatory authorities (CDSCO, USFDA, EMA, WHO, etc.) for timely submissions and approvals.
- Guide preparation, review, and submission of dossiers, CTD/eCTD, and other regulatory documents.
- Ensure compliance with labeling, packaging, and promotional material as per regulatory guidelines.
- Provide regulatory support during audits, inspections, and product development stages.
- Collaborate with R&D, QA, QC, Production, and Marketing teams for smooth regulatory processes.
- Monitor updates in global regulations and communicate changes to relevant stakeholders.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)
Key Skills
Attention to DetailCommunicationTeam WorkProblem Solving
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