Olon Active Pharmaceutical Ingredients India Priva Te
|
Mumbai
20 Oct
Olon Active Pharmaceutical Ingredients India Priva Te
Mumbai
Roles and Responsibilities :
- Ensure compliance with regulatory requirements for drug products in the US market, including FDA regulations (USFDA) and MHRA guidelines.
- Prepare and submit applications to regulatory authorities, such as ANDA submissions to the FDA.
- Collaborate with cross-functional teams to develop and implement quality control processes for API manufacturing facilities.
- Provide technical support to customers on regulatory matters related to active pharmaceutical ingredients (APIs).
Job Requirements :
- 7-12 years of experience in Regulatory Affairs or a related field within the pharmaceutical industry.
- Robust understanding of DMF, CTD, EENT, SR, ICH guidelines and regulations governing drug development and approval.
- Experience preparing dossiers for regulatory submissions (e.g., ANDA) and maintaining accurate records throughout product lifecycle.
📌 API-Regulatory Affairs Executive (Mumbai)
🏢 Olon Active Pharmaceutical Ingredients India Priva Te
📍 Mumbai
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