RA Executive (Khopoli)

Job Description :

Position : RA Executive (Khopoli)

Location : Khopoli - Raigarh

Experience : 5 - 6 Years

Industries : Pharma

Responsibilities :

• Dossier Preparation & Submission
• Prepare compile and review CTD / ACTD / eCTD dossiers for product registration in global markets.
• Coordinate for ANDA DMF CEP COS and other regulatory submissions for APIs and formulations.
• Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements.
• Regulatory Compliance & Communication
• Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines.
• Review and submit annual reports amendments variations and renewals as required.
• Communicate with regulatory agencies and address queries deficiencies and clarifications (Q&A) in a timely manner.
• Documentation & Data Collection
• Coordinate with R&D QA QC Production and Supply Chain teams to gather necessary technical documents.
• Maintain and update regulatory databases trackers and registration status reports.
• Change Control & Lifecycle Management
• Evaluate regulatory impact of change controls and ensure timely submission of variations.
• Support post-approval submissions and product updates in different markets.
• Audit & Inspection Support
• Provide regulatory support during internal and external audits (e.g. USFDA MHRA WHO-GMP).
• Maintain audit-ready regulatory documentation.

Required Skills

Required Qualification : - : - Upto 7 .00 LPA

If you are interested for this opening please send updated resume on or revert on same mail with following details.

Total No. of Years Experience : -

Current CTC : -

Expected CTC : -

Notice Period : -

Key Skills

Campaigns,Animal Care,Anti Money Laundering,Endpoint Security,ABAP,KG Teaching

Employment Type : Full-Time

Experience : years

Vacancy : 1