Job Description
Regulatory Knowledge & Compliance
- Demonstrate strong understanding of the Drugs and Cosmetics Act, Central Drugs Standard Control Organization, Guidance for Industry, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Regulations, and Narcotic Drugs and Psychotropic Substances Act.
- Ensure compliance with all applicable regulatory requirements for pharmaceutical products.
CDSCO Regulatory Submissions
- Strategize, prepare, submit, and obtain approvals for:
- FORM 11, CT-17, CT-04, CT-21, CT-18
- Form 10
- MD-5, MD-6, MD-15, MD-17
- Dual NOC applications
- Ensure timely approvals and proactive follow-up with authorities.
State FDA Approvals
- Manage end-to-end approvals from State FDA, including:
- Test Licenses
- Manufacturing Licenses
- Export & Domestic Licenses
- COPP, FSC
- Loan Licenses
- WHO-GMP, State GMP/GLP certifications
CBN Regulatory Coordination
- Liaise with Central Bureau of Narcotics (CBN) for:
- Export Authorizations
- Import Authorizations
Cross-Functional Collaboration
- Work closely with cross-functional teams (CFTs) including:
- R&D
- Quality Assurance / Quality Control
- Manufacturing
- Supply Chain & Logistics
- Marketing
- Ensure regulatory strategies are aligned and implemented effectively.
Regulatory Strategy in Product Development
- Provide regulatory guidance during product development stages.
- Define clear pathways for approvals in India and support global regulatory submissions.
Regulatory Systems & Portals
- Hands-on experience with regulatory portals:
- SUGAM Portal
- NSWS (National Single Window System)
- IDML
- IFP
- Unified CBN Portal
Regulatory Query Management
- Effectively handle and respond to queries raised by regulatory authorities.
- Ensure timely and accurate submissions to avoid delays in approvals.
Communication & Stakeholder Management
- Possess strong written and verbal communication skills.
- Ability to coordinate with internal teams and external regulatory bodies efficiently.
Qualifications
B.Pharma with Six year of experience
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
