Note:- Minimum Qualification M.Pharma Required
Regulatory Strategy & Planning: Design productive approval pathways (such as IND, NDA, ANDA, or BLA) and advise project teams on global or regional compliance requirements.
Agency Liaison: Serve as the primary point of contact and negotiator with regulatory bodies like the US FDA, EMA, or India’s CDSCO.
Dossier Preparation & Submission: Compile, review, and submit comprehensive technical data, clinical trial applications, and marketing authorization dossiers.
Regulatory Intelligence: Monitor shifting local and international laws, guidelines (such as ICH), and precedent decisions to assess portfolio impact.
Lifecycle Management: Oversee post-approval changes including manufacturing updates (CMC),



label revisions, renewals, and line extensions.
Compliance & Quality Assurance: Ensure adherence to Positive Laboratory, Clinical, and Manufacturing Practices (GxP) during research, trials, and production.

Pay: ₹25,000.00 - ₹80,000.00 per month

Advantages:
Flexible schedule
Food provided
Leave encashment
Life insurance
Paid sick time
Paid time off
Provident Fund

Education:
Master's (Required)

Experience:
Dra: 2 years (Required)

Work Location: In person

📌 Drugs Regulatory Affairs Executive Roorkee
🏢 ASPIRIT VISION SOLUTION
📍 Roorkee