Senior Regulatory Affairs Associate
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Job Description
Senior Regulatory Affairs Associate managing life-cycle regulatory submissions for Parexel’s clinical development solutions. Handling CMC authoring, health authority responses, variations, and post-approval updates across global markets.
Responsibilities:
- Contribute to the preparation, including relevant authoring, and delivery of simple and increasingly complex regulatory maintenance submissions from global and/or regional perspectives
- Author and review CMC components of Marketing Authorization Applications and Variations for medicinal products filed in the EU
- Prepare documentation for Super Grouping, Grouping, and Work-sharing variation procedures
- Review DMFs, batch records, specifications, and stability data for regulatory compliance
- Author CMC components of annual reports, renewals, GMP submissions, and site registrations
- Provide regulatory impact assessments for change controls and identify required documentation for EU/US and other-market submissions
- Liaise closely with cross-functional members with aligned product responsibilities
- Execute and maintain submission delivery plans and submission content plans
- Proactively provide status updates to designated stakeholders
- Prepare, review, and submit safety variations to Health Authorities
- Perform post-approval CMC-related updates
- Author label content for the EU, Canada, Australia/New Zealand, and US based on CCDS, PRAC, and CMDH recommendations
- Guide and mentor team members
Requirements:
- Relevant experience handling life cycle management of approved drug products, including small molecules and biologicals such as vaccines and monoclonal antibodies, across various markets
- Good understanding of regulatory frameworks and regional trends for various application types and procedures
- Working knowledge of EU/US regulatory procedures, including post-approval requirements
- Experience handling CMC-related health authority queries and authoring responses
- Knowledge of global pharmaceutical legislation and ICH regulatory CMC guidance
- Experience authoring and reviewing CMC components of Marketing Authorization Applications and Variations for oral and parenteral medicinal products
- Experience with EU DCP, MRP, and National Procedures
- Experience preparing Super Grouping, Grouping, and Work-sharing variation documentation
- Experience reviewing DMFs, batch records, specifications, and stability data for regulatory compliance
- Experience authoring CMC components of annual reports, renewals, GMP submissions, and site registrations
- Experience providing regulatory impact assessments for change controls and identifying documentation requirements
- Experience with Regulatory Information Management Systems such as Veeva Vault
- Strong communication skills and ability to guide and mentor team members
- Ability to work independently
- Familiarity with EU Guidelines for QRD and Excipients
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