Regulatory Labeling Specialist Jobs – Biocon Hiring in Bangalore

M.Pharm/MSc Regulatory Labeling Specialist Jobs – Biocon Hiring in Bangalore

Biocon is hiring M.Pharm/MSc professionals with 5–10 yrs exp. for Regulatory Labeling Specialist role in Bengaluru. Apply now for this strategic role!

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Biocon Hiring Regulatory Labeling Specialists | M.Pharm / MSc | 5–10 Years Exp | Bangalore

Are you a skilled Regulatory Affairs professional with experience in labeling and global submissions? Here’s a great opportunity! Biocon, one of India’s leading biopharmaceutical companies, is actively hiring for the Regulatory Labeling Specialist role at its Bangalore office. This opportunity is ideal for M.Pharm or MSc graduates with 5 to 10 years of relevant experience in handling US-FDA, Health Canada, and EU submissions.

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Job Designation & Role Overview

Position: Regulatory Labeling Specialist (Assistant Manager / Deputy Manager)
Department: Regulatory Affairs – US/Canada
Location: Bengaluru, Karnataka
Type: Full-time, Onsite (5 days working)

The Regulatory Labeling Specialist will play a strategic and tactical role within Biocon’s Global Regulatory Affairs team, responsible for preparing, reviewing, and submitting Structured Product Labeling (SPL) and ensuring compliance with regional requirements for labeling submissions (US, Canada, EU).

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Key Responsibilities

Regulatory Labeling and Submissions

• Preparation, review, and submission of high-quality regulatory submissions such as ANDAs, MAs, amendments, annual reports, and REMS.

• Ensure timely drug listing activities and structured product labeling (SPL) submissions to the US FDA.

Labeling Compliance & Coordination

• Develop and review product labeling (PIL, SMPC, product monograph, and artworks) in compliance with global regulatory standards.

• Collaborate with IP teams to align labeling content with patent certifications.

Monitoring and Updates

• Keep track of RLD/Reference product labeling changes for timely amendments/supplements/variations.

• Provide accurate artwork and labeling content and coordinate with design teams for final approval.

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 Required Qualifications & Experience

Educational Qualification

• M.Pharm (Master of Pharmacy)

• MSc (Master of Science in Life Sciences or related domain)

Experience Required

• 5 to 10 years in Regulatory Affairs, with strong expertise in regulatory labeling

• Hands-on experience in working with labeling tools and preparing global submissions

• Deep understanding of US FDA, Health Canada, and EU regulatory guidelines

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Skills & Competencies

• Strong documentation and review skills

• Knowledge of Structured Product Labeling (SPL)

• Familiarity with Drug Listing procedures

• Ability to work cross-functionally and manage timelines

• Detail-oriented with excellent communication skills

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✉️ How to Apply?

Interested candidates with relevant experience are encouraged to email their CV to:
📩 rashmi.gupta@biocon.com

When applying, include the following details:

• Total Experience

• Current CTC

• Regulatory Labeling Experience

• Notice Period

• Willingness to relocate to Bangalore

Note: Onsite role (5 Days Working) – Candidates must be open to working from Bangalore.

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