Senior Regulatory Affairs Associate (FDA expertise)

Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities. This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence crossu2011functional teams in a fastu2011changing environment. Key Responsibilities: Documentation & Compliance u2022 Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements. u2022 Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). u2022 Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals. Regulatory Submissions u2022 Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. u2022 Provide local input for change control and post-approval requirements. u2022 Collaborate with global functions to obtain documentation aligned with local requirements. Audit & Inspection Support u2022 Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure. u2022 Provide local expertise and responses to inspection queries. Cross-Functional Collaboration u2022 Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes. u2022 Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies. Strategic Leadership u2022 Lead regulatory strategies for product launches and integrations at the affiliate level. u2022 Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships. u2022 Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation. Education u2022 Bacheloru2019s degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent. u2022 Advanced degree (Masteru2019s or PhD) preferred in law, legal affairs, or natural sciences. u2022 Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus. Experience u2022 3u20135+ years of local regulatory knowledge and experience in a health authority-facing role. u2022 Demonstrated previous life cycle management experience is required. u2022 Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. u2022 Proven expertise in managing regulatory submissions, timelines, and cross-functional teams. u2022 Strong project management and leadership skills. u2022 Experience influencing Commercial Operations stakeholders and driving business-critical decisions. u2022 Demonstrated ability to adapt and succeed in rapidly changing environments. #LI-LB1 #LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Created: 2025-12-22