Senior Regulatory Affairs Associate- CMC Biologics

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Senior Regulatory Affairs Associate (Biologics/Small Molecules) Around 4-6 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective. Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage Experience in handling CMC related health authority queries, and author responses to HA requests Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures). Preparation of documentation for different types of Variation procedures like Super Grouping, Grouping and Work-sharing to the Marketing Authorizations. Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements. Author CMC components of Annual Reports and renewals (m 1/2/3), GMP submissions e.g., site registrations Providing regulatory impact assessment for any change control and identification of required documentation for EU/US submissions and other markets. Liaise closely with cross-functional members with aligned product responsibilities. Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates. Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault. Strong communications skills and ability to guide and mentor team members, and ability to work independently. Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations. Familiarity with EU Guidelines for QRD / Excipients.