Senior Manager- - US ANDA Submissions, Project Management

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.

What We Offer:

• Competitive compensation package with performance-based incentives.
• Opportunities for professional growth and leadership roles.
• A collaborative and innovation-driven work environment.

Interested Candidates are encouraged to send their CV and Cover letter to Purnima.chauhan@walterbushnell.com