Manager-2 -Regulatory Labelling

Job Title:

Manager 2 - Regulatory Labelling

Business Unit:

Clinical Development

Job Grade

G11A/11B

Location :

Gurgaon/Mumbai

Create your own sunshine

As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys.

Job Purpose

The Global Labelling Lead (GLL) will ensure the creation, maintenance, and compliance of global labelling documents throughout the product lifecycle. This role is critical for safeguarding regulatory compliance, patient safety, and consistency of product information across global markets.

Key responsibilities:

• Develop and maintain Company Core Data Sheets (CCDS), including Core Safety Information (CSI), with periodic reviews and updates throughout the product lifecycle.


• Perform labelling content gap analysis through multiple label comparisons.


• Ensure CCDS content is implemented into Local Product Information within required timelines across multiple markets.


• Review and assess local country labels to identify deviations from core labelling and propose topics for cross-functional assessment during periodic reviews.


• Highlight key country label proposals that deviate from CCDS or amendments (e. g. , USPI, EU SmPC).


• Prepare and review global and regional labelling documents, including prescribing information, patient leaflets, and packaging components.


• Review and approve packaging artworks for compliance with approved labelling and regulatory standards.


• Collaborate with Regulatory Affairs, Safety, Medical, and Commercial teams to ensure alignment on labelling content.


• Support global and local affiliates during implementation of labelling changes.


• Maintain accurate records of labelling changes and approvals, ensuring adherence to SOPs and regulatory guidelines.

Qualification, Skill and Competencies Requirements

• Bachelor s degree in Pharmacy, Life Sciences, or related field (Master s preferred).


• 6-7 years of experience in regulatory labelling and artwork within the pharmaceutical industry.


• Strong understanding of global regulatory requirements for labelling.


• Excellent attention to detail and organizational skills.


• Proficiency in document management systems and artwork tools.


• Strong communication and stakeholder management skills.

Travel Estimate

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure : 6 to 8 years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let s create a brighter future together!

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