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Global Regulatory Labeling Specialist

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Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Job Description

Key stakeholders for this role include sales, marketing, manufacturing, supply chain, medical affairs, quality assurance, quality control, pharmacovigilance, planning, project management, and senior management.

The reporting structure involves collaborating with the regulatory affairs labeling manager.

This position requires at least 4 years of relevant regulatory experience, preferably globally in the US, EU, and major rest-of-world markets.

The ideal candidate will possess strong interpersonal and organizational skills, as well as in-depth knowledge of health authority labeling regulations and requirements.

A self-motivated, organized, and adaptable individual with a high level of accountability is required. Excellent work ethic and a positive, proactive attitude are also essential.

Additionally, project management skills are advantageous.

Required Skills and Qualifications
  • Regulatory Labeling Experience: At least 4 years of relevant global experience in the US, EU, and major rest-of-world markets.
  • Health Authority Labeling Regulations: In-depth knowledge of health authority labeling regulations and requirements.
  • Collaboration and Communication: Strong interpersonal and organizational skills for effective collaboration with cross-functional teams.
Benefits

This role offers the opportunity to manage global labeling details, including labels, cartons, package inserts, and patient package inserts to ensure compliance, quality, and accuracy. You will collaborate with cross-functional teams for regulatory submissions, evaluations, and approvals.

You will prepare labeling-related documents, such as SmPC, PIL, and other texts for EU submissions. Additionally, you will coordinate with stakeholders to ensure timely submission and approval of labeling, and address any related queries.

You will proofread all types of label copy and annotations at various developmental stages to ensure accuracy. Furthermore, you will create Structured Product Labeling (SPL) for US Human and Veterinary product submissions, including drug listings, annual establishment registration, and GDUFA self-identification.

You will monitor and process innovator-labeling updates for existing generic products, ensuring compliance with innovator updates through side-by-side comparisons with reference listed drugs (RLDs). Moreover, you will oversee the development and updates of Core Data Sheets (CCDS) for PCC products and manage local labeling updates.

You will contribute to the development and review of labeling aspects in promotional materials. Lastly, you will develop and maintain a central repository for all labeling components.

Qualifications

Bachelor's or Master's degree in pharmacy (B.Pharm or M.Pharm)