Senior Regulatory Affairs Associate

Responsibilities

• Manage the life-cycle of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies).
• Prepare, author, and deliver regulatory maintenance submissions and complex global/regional submissions.
• Handle CMC-related Health Authority (HA) queries and author formal responses.
• Author and review CMC components of Marketing Authorization Applications (MAAs) and Variations.
• Perform regulatory reviews of DMFs, batch records, specifications, and stability data to ensure compliance.
• Provide regulatory impact assessments for change controls and identify required documentation for EU, US, and other markets.
• Maintain labeling content for EU, US, Canada, and Australia/New Zealand markets.
• Utilize Regulatory Information Management Systems (RIMS) such as Veeva Vault to execute submission plans.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline.
• Proven experience in the life-cycle management of approved drug products.
• Strong understanding of EU and US regulatory procedures and post-approval requirements.
• Experience handling CMC-related Health Authority queries.
• Proficiency with Regulatory Information Management Systems (RIMS) like Veeva Vault.

Preferred Qualifications

• Master's degree in a relevant scientific field.
• Knowledge of regulatory legislation in Rest of World (ROW) markets.
• Experience with EU QRD template requirements and European Commission guidelines on excipients.

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. We are dedicated to advancing science with a patient-centric approach, offering a supportive, inclusive, and flexible remote work environment for our global team of experts.