Sr. Manager - US ANDA Submissions, Project Management & API Sourcing

Job Description

Job Title: Senior Manager - US ANDA Submissions, Project Management & API Sourcing Location: Gurgaon, India Job Summary: We are looking for an experienced Senior Manager with a strong background in US ANDA submissions, project management, and API sourcing to drive our business growth in the US markets. The ideal candidate will have a comprehensive understanding of regulatory requirements and project lifecycle management, ensuring timely and cost-effective delivery of projects. Key Responsibilities: • Regulatory Submissions: Lead and manage US ANDA submission processes, ensuring compliance with FDA requirements. Collaborate with regulatory affairs teams to prepare and review dossiers. • Project Management: Oversee end-to-end project management for ANDA filings, from conceptualization to commercialization. Develop and manage project timelines, budgets, and resource allocation. Coordinate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to meet project milestones. • API Sourcing & Vendor Management: Identify and evaluate reliable API suppliers for US market projects. Negotiate contracts and ensure cost-effective procurement while maintaining quality standards. Establish and maintain strong relationships with suppliers and vendors. • Compliance &Documentation: Ensure adherence to regulatory guidelines and company policies in all processes. Maintain accurate documentation for submissions, approvals, and communications with regulatory authorities. • Market & Industry Analysis: Monitor market trends and competitor activities to identify opportunities and challenges. Provide insights to support strategic decision-making for US market expansion. Qualifications & Experience: • Bachelors degree in Pharmacy, Chemistry, or a related field (MBA or advanced degree preferred). • Minimum of 10 years of experience in US ANDA submissions, project management, and API sourcing. • In-depth knowledge of FDA regulations and submission processes for US markets. • Proven track record of successful project delivery within stipulated timelines and budgets. • Strong negotiation, leadership, and problem-solving skills. • Proficiency in project management tools, ERP systems, and MS Office Suite. Key Competencies: • Strong regulatory knowledge and attention to detail. • Excellent project planning and organizational skills. • Effective communication and interpersonal abilities. • Ability to manage multiple projects and priorities simultaneously. Interested Candidates can share their resumes at shikha.mishra@walterbushnell.com