API-Regulatory Affairs Executive (Mumbai)

API-Regulatory Affairs Executive (Mumbai)

15 Oct
|
Olon Active Pharmaceutical Ingredients India Priva Te
|
Mumbai

15 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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