API-Regulatory Affairs Executive

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.