Assistant Manager/ Deputy Manager - Labelling

Azurity Pharmaceuticals is seeking an Assistant Manager/Deputy Manager - Labelling to join our team in Hyderabad, India. This role is integral to our Regulatory Affairs department, focusing on the development and implementation of pharmaceutical drug product labeling for both pipeline and commercial products across global markets, including FDA, EMA, Health Canada, GCC, APAC, LATAM, and other emerging regions. The successful candidate will ensure compliance with applicable regulations, guidelines, and company standards, contributing to our mission of providing innovative and high-quality medications to underserved patients.

The primary responsibilities include overseeing regulatory labeling activities throughout the product lifecycle, from development through post-approval, ensuring timely submissions and adherence to international health authority requirements. The role involves initiating and monitoring new and revised labeling requests, preparing and updating labeling components such as SmPC, PIL, USPI, carton/container labels, and electronic formats (e.g., SPL, XML) for global submissions. Additionally, the candidate will coordinate with artwork preparation teams, initiate and approve change controls, participate in weekly Labeling Management Review Committee meetings, and monitor global regulatory changes impacting product labeling.

Candidates should possess the ability to read, understand, and follow health authority regulations and guidance documents related to labeling. Proven experience collaborating within cross-functional teams, strong attention to detail, and the ability to manage multiple tasks simultaneously are essential. Strong interpersonal and communication skills, a sense of teamwork, and familiarity with Regulatory Information Management (RIM) systems like Veeva Vault or similar platforms are also required. The ideal candidate will have 8-12 years of pharmaceutical labeling experience and a Bachelor's or Master's degree in a scientific discipline.

Azurity Pharmaceuticals offers a dynamic and inclusive work environment where employees are encouraged to grow and develop their careers. We provide opportunities for professional advancement, a collaborative culture, and the chance to contribute to meaningful work that impacts patients' lives globally. Joining our team means becoming part of a company that values dedication, integrity, and creative spirit.