Deccan Nutraceuticals Pvt Ltd

Alandi Road, Pune

Key Responsibilities: Strategic Leadership: Develop and implement regulatory strategies for new and existing products, ensuring alignment with company objectives and global regulatory requirements. Submission Management: Prepare, review, and submit high-quality regulatory dossiers to regulatory agencies (e.g., FDA, EMA) for product registrations, variations, and renewals. Compliance Assurance: Monitor and interpret evolving regulations, guidelines, and standards to ensure ongoing compliance and proactively address potential risks. Collaboration & Communication: Collaborate effectively with cross-functional teams (R&D, Quality, Manufacturing) to provide regulatory guidance and support throughout the product lifecycle.Requirements: Regulatory Expertise: In-depth knowledge of global pharmaceutical regulations, guidelines, and standards (e.g., ICH, GMP). Strategic Thinking: Ability to develop and implement effective regulatory strategies aligned with business objectives. Communication & Collaboration: Excellent written and verbal communication skills with the ability to build strong relationships with internal and external stakeholders. Problem-Solving & Decision-Making: Analytical and problem-solving skills with the ability to make sound decisions in a complex regulatory environment. Leadership & Management: Proven ability to lead and motivate a team, providing guidance and support to achieve departmental goals.Education Required : Proven experience as a Regulatory Affairs Manager in the pharmaceutical industry. Strong understanding of drug development and manufacturing processes. Excellent knowledge of regulatory submission requirements and procedures