Regulatory Affairs Labeling Specialist (Fully Remote)

Jobgether; United States; Remote; USD 60,000 - 110,000; Full time

Job summary

Jobgether is seeking a regulatory labeling specialist to manage labeling activities for medicinal products across multiple procedures. You will coordinate with internal and client teams to ensure accuracy and compliance of product information and submit variations and renewals to Health Authorities.

The role requires a life sciences degree and at least 6 years in regulatory affairs or labeling, with strong knowledge of Veeva RIMS and TrackWise.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field.
• At least 6 years of experience in regulatory affairs or labeling.
• Proficient knowledge of regulatory procedures, Veeva RIMS, and TrackWise.

Responsibilities

• Manage regulatory labeling activities for medicinal products across multiple procedures.
• Ensure accurate and compliant product information through collaboration with internal and client teams.
• Conduct regulatory impact assessments and maintain product information documentation.
• Prepare and submit variations, notifications, and renewals to Health Authorities.
• Coordinate labeling updates, translations, and post-approval activities in Veeva RIMS.

Skills

Regulatory knowledge

Team collaboration

Education

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field

Tools

Veeva RIMS

TrackWise

Job description

• Manage regulatory labeling activities for medicinal products across multiple procedures.
• Ensure accurate and compliant product information through collaboration with internal and client teams.

Responsibilities:

• Conduct regulatory impact assessments and maintain product information documentation.
• Prepare and submit variations, notifications, and renewals to Health Authorities.
• Coordinate labeling updates, translations, and post-approval activities in Veeva RIMS.

Requirements:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field.
• At least 6 years of experience in regulatory affairs or labeling.
• Strong knowledge of regulatory procedures, Veeva RIMS, and TrackWise.
• Work remotely from India with international team exposure.
• Access continuous learning and career growth opportunities.
• Contribute to meaningful patient-focused regulatory compliance.

Jobgether

A global clinical research organization dedicated to improving patient outcomes through regulatory affairs and medicinal product compliance. It fosters a collaborative, patient-focused culture with opportunities for professional development.