Deputy Manager - Labelling

Azurity Pharmaceuticals; Hyderabad; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Azurity Pharmaceuticals is seeking an experienced regulatory labeling professional to lead development and implementation of labeling for pipeline and commercial products worldwide. You will ensure compliance with FDA, EMA, Health Canada, GCC, APAC, LATAM, and other regions, coordinating with QA, Regulatory, and Manufacturing teams.

The role requires strong experience with HA regulations, RIM systems like Veeva Vault, and collaboration across packaging, marketing, medical affairs, and vendors.

Qualifications

• Knowledge of HA regulations and guidance for labeling.
• Experience collaborating within cross-functional teams to meet objectives.
• Excellent attention to detail and ability to meet deadlines.
• Strong prioritization and multitasking abilities.
• Excellent communication across phone, email, web-ex, and in person.
• Strong teamwork and relationship-building.
• Proactive in identifying and escalating issues to ensure resolution.
• Familiar with Regulatory Information Management (RIM) systems like Veeva Vault.
• Able to work with large datasets and detailed documentation.

Responsibilities

• Oversee global labeling activities across the product lifecycle, ensuring compliance and timely submissions.
• Serve as SME for global labeling regulations, standards and best practices.
• Coordinate, monitor and expedite labeling changes to meet HA submission timelines.
• Prepare and update labeling components for global submissions (SmPC, PIL, USPI, labels).
• Archive controlled label copies and maintain version control.

Skills

Regulatory labeling

Cross-functional collaboration

Deadline driven

Multitasking

Communication

Teamwork

Issue escalation

RIM systems (Veeva Vault)

Data handling

Education

Bachelor’s/Master’s degree in life sciences or related

Regulatory affairs certification (RAC)

Job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Role And Responsibilities

Role

Responsible for development and implementation of new and revised pharmaceutical drug product labeling for both pipeline and commercial products across global market (including FDA, EMA, Health Canada, GCC, APAC, LATAM, and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards.

Key Responsibilities

• Oversee regulatory labeling activities across the entire product lifecycle from development through post-approval, ensuring timely submissions and adherence to international health authority requirements.
• Act as a subject matter expert for global labeling regulations, standards and best practices.

Responsibilities

• Initiate and monitor the process for new and revised labeling requests according to internal procedures.
• Prepare and update labeling components such as SmPC, PIL, USPI, carton/container labels, and electronic formats (e.g., SPL, XML) for global submissions.
• Ensure regulatory compliance, accuracy, and version control of all new and revised labeling.
• Coordinate, monitor, and expedite labeling changes to meet established deadlines for HA submission and/or production schedules.
• Coordinating with artworks preparations team for development of label / cartons / package insert for submission purposes.
• Initiate and approve change controls for new and revised labeling.
• Participate in Azurity’s Labeling Management Review Committee (LMRC) weekly meetings to finalize and approve labeling.
• Develop collaborative and respectful relationships with internal and external customers, including but not limited to, Packaging Operations, Marketing, Medical Affairs, Regulatory Affairs, Supply Chain, and artwork and print vendors to develop labeling.
• Monitor and update the labeling tracker to ensure timely progress and adherence to project timelines.
• Monitor global regulatory changes, guidance documents, and safety updates that impact product labeling.
• Archive controlled label copies and master label files according to internal procedures.

Required Skills And Experience

• Ability to read, understand, and follow HA regulations and guidance documents related to labeling.
• Proven experience collaborating within cross-functional teams to achieve shared objectives.
• Strong attention to detail and ability to meet deadlines
• Highly skilled at prioritizing and managing multiple tasks simultaneously.
• Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person)
• Strong sense of teamwork, ability to build collaborative relationships.
• Adept at identifying, addressing, and escalating issues promptly to ensure resolution.
• Familiar with Regulatory Information Management (RIM) systems like Veeva Vault and/or similar platforms.
• Ability to work with large datasets and detailed documentation.

Preferred Qualifications

• 8-12 years of pharmaceutical labeling experience.
• Bachelor’s/ Master’s degree in scientific discipline preferred.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.