Senior Regulatory Affairs Associate- Labeling Strategy (Fully Remote)

Confidential; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Remote work

Career development opportunities

Job summary

Confidential, a pharmaceutical organization, seeks a regulatory affairs expert focused on labeling strategies. You will develop and maintain global labeling documents such as CCDS, USPI, and regional labels to ensure regulatory compliance and patient access, in a fully remote setup based in India.

The role requires 7-8 years of labeling-focused regulatory experience, a Life Sciences/Pharmacy/Chemistry degree, and proficiency in SPL and document management systems to support global markets

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or equivalent experience.
• 7-8 years of pharmaceutical regulatory affairs experience with labeling expertise.
• Proficiency in SPL and document management systems.

Responsibilities

• Develop and maintain global labeling documents including CCDS, USPI, and regional labels.
• Manage post-approval labeling activities, safety variations, and regulatory submissions.
• Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.

Skills

Regulatory affairs experience

Labeling expertise

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Life Sciences/Pharmacy/Chemistry

Tools

SPL

Document management systems

Job description

• Contribute to the development and lifecycle management of pharmaceutical labeling strategies.
• Ensure regulatory compliance and improve patient access to innovative treatments.

Key Responsibilities:

• Develop and maintain global labeling documents including CCDS, USPI, and regional labels.
• Manage post-approval labeling activities, safety variations, and regulatory submissions.
• Collaborate with cross-functional teams to ensure accurate, timely, and compliant product information.

Requirements:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or equivalent experience.
• 7-8 years of pharmaceutical regulatory affairs experience with labeling expertise.
• Proficiency in SPL and document management systems.
• Fully remote working arrangement based in India.
• Professional development and career growth opportunities.
• International collaboration across global markets.

Confidential

The hiring company is a pharmaceutical organization focused on developing and maintaining labeling strategies for innovative treatments. It offers a globally connected remote work environment that values precision, collaboration, and continuous professional development.