API-Regulatory Affairs Executive

Olon Active Pharmaceutical Ingredients India Priva Te; Mumbai, Thane, Navi Mumbai; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Olon Active Pharmaceutical Ingredients India Priva Te is seeking an experienced Regulatory Affairs professional to ensure compliance with US FDA and MHRA guidelines for drug products intended for the US market. The role involves collaboration with cross-functional teams to implement quality control processes at the API manufacturing facilities.

The ideal candidate has 7–12 years in regulatory affairs within pharma, strong knowledge of DMF/CTD/ICH guidelines, and experience preparing ANDA

Qualifications

• 7-12 years of experience in Regulatory Affairs or a related field within the pharmaceutical industry.
• Strong 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.

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.

Job description

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.
• Strong 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.