Assistant Manager/ Deputy Manager - Labelling

Why This Role Matters
The Assistant Manager/Deputy Manager – Labelling plays a pivotal role in ensuring that all pharmaceutical product labeling is accurate, compliant, and aligned with global regulatory requirements. This position supports Azurity Pharmaceuticals’ commitment to patient safety and regulatory excellence by overseeing labeling activities across the product lifecycle for both pipeline and commercial products.

Job Description
Based in Hyderabad, this position is responsible for the development, implementation, and maintenance of pharmaceutical drug product labeling for global markets, including FDA, EMA, Health Canada, GCC, APAC, LATAM, and emerging regions. The role ensures compliance with applicable regulations, internal guidelines, and company standards while collaborating with cross-functional teams.

Key Features of the Role
• Oversee regulatory labeling activities from development through post-approval.
• Act as a subject matter expert for global labeling regulations, standards, and best practices.
• Initiate and monitor 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 (SPL, XML) for global submissions.
• Ensure regulatory compliance, accuracy, and version control of all labeling materials.
• Coordinate and expedite labeling changes to meet submission or production deadlines.
• Collaborate with artwork preparation teams for label/carton/package insert development.
• Initiate and approve change controls for labeling updates.
• Participate in Labeling Management Review Committee (LMRC) meetings to finalize approvals.
• Maintain collaborative relationships with internal and external stakeholders including Packaging Operations, Marketing, Medical Affairs, Regulatory Affairs, Supply Chain, and vendors.
• Monitor global regulatory updates affecting labeling requirements.
• Archive controlled label copies and master label files per internal procedures.

Responsibilities
• Manage the creation, review, and approval of global product labeling.
• Ensure compliance with international health authority regulations and internal standards.
• Collaborate with cross-functional teams to achieve timely and accurate labeling outcomes.
• Track labeling progress, maintain records, and ensure adherence to timelines.
• Monitor and implement global regulatory changes impacting product labeling.
• Escalate and resolve labeling issues proactively.

Required Qualifications
• Bachelor’s or Master’s degree in a scientific discipline preferred
• 8-12 years of pharmaceutical labeling experience preferred

Educational Requirements
• Bachelor’s or Master’s degree in life sciences, pharmacy, or related field preferred

Experience and Skills
• Strong knowledge of global health authority regulations and labeling guidance
• Experience in pharmaceutical labeling across international markets
• Excellent attention to detail and organizational skills
• Ability to manage multiple tasks and deadlines simultaneously
• Strong interpersonal and communication skills for collaboration across teams and vendors
• Experience with Regulatory Information Management (RIM) systems such as Veeva Vault or similar
• Proficiency in managing large datasets and detailed documentation

Salary Insights
• Compensation based on company standards; details discussed during recruitment

Company Overview
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company delivering innovative medicines for underserved patients across multiple therapeutic areas. It emphasizes patient-centric solutions, high-quality products, and an inclusive workplace culture.

FAQs
• Who can apply?
Candidates with extensive pharmaceutical labeling experience and relevant scientific qualifications.
• Is this an office-based role?
Yes, based in Hyderabad with cross-functional collaboration.
• Does the role involve regulatory compliance?
Yes, compliance with global health authority labeling regulations is central to the position.
• Are vendor interactions required?
Yes, collaboration with artwork, print, and packaging vendors is part of the responsibilities.

Application Tips
• Highlight your experience in pharmaceutical labeling for global markets.
• Demonstrate familiarity with international regulatory requirements and RIM systems.
• Showcase your ability to manage multiple labeling projects with accuracy and timeliness.
• Emphasize experience in cross-functional collaboration and vendor management.
• Provide examples of successfully executed labeling changes or compliance initiatives.