Regulatory Affairs Associate

This is a fully remote position, open to applicants in India.

📋 Description

• Conduct Regulatory Impact Assessments (RIA) for Change Controls submitted in TrackWise.

• Evaluate regulatory implications related to changes in manufacturing, quality, labeling, and product information.

• Oversee and maintain regulatory change records in Veeva RIMS.

• Assist in the implementation of regulatory strategies for post-approval modifications.

• Review, revise, and author Module 3 sections of CTD dossiers for medicinal products.

• Ensure that CMC documentation is up-to-date and compliant with regulatory standards.

• Facilitate dossier lifecycle maintenance activities across various markets.

• Perform thorough Gap Analysis of Module 3 documentation.

• Identify compliance risks, data gaps, and deficiencies in documentation.

• Create and recommend remediation plans and regulatory strategies to address identified gaps.

• Manage post-approval regulatory activities throughout the product lifecycle.

• Support the maintenance of marketing authorizations across EU markets.

• Work collaboratively with cross-functional teams to ensure the timely execution of regulatory obligations.

⛳️ Requirements

• Minimum of 3 years of experience in post-approval regulatory activities.

• Familiarity with medicinal products registered through European procedures, including CP, MRP, DCP, and National Procedures.

• In-depth knowledge of post-approval regulatory activities for medicinal products.

• Experience with regulatory submissions, updates to CMC documentation, and interactions with health authorities.

• Proficient in TrackWise.

• Proficient in Veeva RIMS.

• Experience in reviewing, updating, and authoring Module 3 sections of CTD dossiers.

• Understanding of relevant regulatory requirements and expectations.

• Experience in conducting comprehensive gap analyses of Module 3 documentation.

• Ability to recognize compliance risks, data gaps, and deficiencies in documentation.

• Capability to develop remediation plans and regulatory strategies.

• Proven ability to collaborate with cross-functional teams and fulfill regulatory commitments in a timely manner.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Supportive work environment that values collaboration and innovation.