Assistant Manager-Regulatory Affairs

Job Description:

Responsibilities

• Artwork Management (all components) Understanding and operational efficiency of artwork management system.
•  Artwork requests to be raised with India specific annotations.
•  Comments received from overseas sites to be addressed and post peer review, approve final artwork files as per artwork approval checklist. Coordination with packaging coordinator, supply chain, BU/ Pricing / Legal team wherever required.
•  Support for QR code / serialization implementation as per business and regulatory needs.
•  Review and impact assessment of new India regulations relevant to labels if any. Ensure implementation as per timelines in coordination with local/ global stakeholders.
•  Support artwork developed for local partners as applicable.
•  Support labels of neighbouring markets e.g. Nepal as needed.
•  Prepare for audit of labeling activity if any and implement CAPAs if applicable.
•  Liaison closely with overseas manufacturing site for labels of 1st launch batch, exploring innovative options for early launch.
•  Ensure 100?herence to internal and external labelling requirements.
• Internal customers
• Marketing, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA
• External customers Local Health Authorities and other Government Agencies

Qualification & Expeirence

• B. Pharm/ M. Sc 3-6 yrs Experience in India Artwork requirement and knowledge of D&C act for Artwork checklist. Should be conversant with Indian regulations in Artwork development.