Manager, Regulatory Affairs
Azurity Pharmaceuticals is seeking a Manager of Regulatory Affairs to join our team in Hyderabad, India. As a privately held specialty pharmaceutical company, Azurity focuses on developing innovative products that address the needs of underserved patients across various therapeutic areas, including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets. The Regulatory Affairs team plays a critical role in ensuring compliance with global regulatory standards and facilitating the approval and lifecycle management of our diverse product portfolio.
The Manager of Regulatory Affairs will oversee and manage regulatory activities for assigned products and projects, serving as the primary regulatory representative on cross-functional teams. Key responsibilities include developing and implementing regulatory strategies for drug product registration and lifecycle management across global markets, with a primary focus on North America. The role involves managing regulatory filings such as IND, NDA, ANDA, and NDS for various dosage forms, including solid oral, parenteral, liquids, inhalation, nasal, and drug/device combination products. Additionally, the manager will establish and manage timelines for regulatory submissions, maintain archives of regulatory documents, and provide guidance on post-approval changes to ensure ongoing compliance.
Candidates should possess a minimum of a Bachelor of Science degree, with advanced degrees such as PharmD, PhD, or Master of Science preferred. A minimum of 8-10 years of experience in the pharmaceutical industry, with at least 8 years in regulatory affairs, is required. The ideal candidate will have excellent organizational, interpersonal, and communication skills, along with proficiency in MS Office. A proven track record of successfully working with cross-functional teams, including external partners, and the ability to work independently in a fast-paced, deadline-driven environment are essential. Attention to detail and the ability to adapt to changing circumstances while ensuring compliance with cGMP and regulatory requirements are also critical.
Azurity Pharmaceuticals offers a dynamic work environment where employees are encouraged to bring their dedication, integrity, and creative spirit to the organization. We are committed to fostering an inclusive workplace and providing opportunities for professional growth and development. Joining our team means contributing to a company that prioritizes patient-centric solutions and values the contributions of its employees.