Job Description

The ideal candidate will be responsible for compiling Drug Master Files (DMFs) ensuring compliance with country specific regulatory guidelines in Emerging markets that includes key markets like Brazil, China, Russia, Taiwan etc. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports. Key Responsibilities: Prepare and submit regulatory dossiers for emerging markets, including Brazil, China, and LATAM. Participate in deficiency meetings, review pending deficiencies, and collaborate with cross-functional teams to ensure timely submission of responses. Manage and evaluate international regulatory projects in alignment with company goals. Plan, coordinate, and submit regulatory dossiers and responses in regulated markets. Review documents, identify gaps, ensure compliance, and facilitate acceptance meetings. Plan amendments, updates, and annual reports, ensuring accurate compilation, review, and submission. Bachelors or Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field. 2-6 years of experience in Regulatory Affairs within the API industry. Strong knowledge of US, EU, and ICH regulatory guidelines. Experience in DMF and CEP compilation, amendments, and annual report filings. Excellent communication and coordination skills to interact effectively with cross- functional teams. Detail-oriented with strong documentation and organizational abilities. Ability to handle multiple regulatory submissions while ensuring accuracy and compliance. Note: Candidates may be considered for positions in Regulatory Affairs specializing in Active Pharmaceutical Ingredients (API) with an interest in working in Emerging Markets (ROW).