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 cross‑functional teams in a fast‑changing environment. Key Responsibilities: Documentation & Compliance • Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements. • Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). • Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals. Regulatory Submissions • Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. • Provide local input for change control and post-approval requirements. • Collaborate with global functions to obtain documentation aligned with local requirements. Audit & Inspection Support • Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure. • Provide local expertise and responses to inspection queries. Cross-Functional Collaboration • Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes. • Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies. Strategic Leadership • Lead regulatory strategies for product launches and integrations at the affiliate level. • Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships. • Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation. Education • Bachelor’s degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent. • Advanced degree (Master’s or PhD) preferred in law, legal affairs, or natural sciences. • Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus. Experience • 3–5+ years of local regulatory knowledge and experience in a health authority-facing role. • Demonstrated previous life cycle management experience is required. • Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes. • Proven expertise in managing regulatory submissions, timelines, and cross-functional teams. • Strong project management and leadership skills. • Experience influencing Commercial Operations stakeholders and driving business-critical decisions. • Demonstrated ability to adapt and succeed in rapidly changing environments. #LI-LB1 #LI-REMOTE Apply tot his job