Senior Regulatory Affairs Associate (FDA expertise)

divh2Senior Regulatory Affairs Associate/h2pBring 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./ppKey Responsibilities:/pulliDocumentation Compliance/liliPrepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements./liliMaintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes)./liliExecute timely data entry and validation in Veeva Vault RIMS for submissions and approvals./li/ululliRegulatory Submissions/liliReview, prepare, and submit dossiers; negotiate with HAs to secure approvals./liliProvide local input for change control and post-approval requirements./liliCollaborate with global functions to obtain documentation aligned with local requirements./li/ululliAudit Inspection Support/liliSupport RA representatives during audits/inspections, ensuring readiness and timely CAPA closure./liliProvide local expertise and responses to inspection queries./li/ululliCross-Functional Collaboration/liliPartner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes./liliAct as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies./li/ululliStrategic Leadership/liliLead regulatory strategies for product launches and integrations at the affiliate level./liliRepresent the company with local HAs, industry groups, and trade associations, fostering positive relationships./liliProvide critical support for promotional material review, interpretation of regulations, and implementation of local legislation./li/ulpEducation:/pulliBachelors degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent./liliAdvanced degree (Masters or PhD) preferred in law, legal affairs, or natural sciences./liliRegional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus./li/ulpExperience:/pulli35+ years of local regulatory knowledge and experience in a health authority-facing role./liliDemonstrated previous life cycle management experience is required./liliComprehensive understanding of regional and global regulatory requirements, guidelines, and processes./liliProven expertise in managing regulatory submissions, timelines, and cross-functional teams./liliStrong project management and leadership skills./liliExperience influencing Commercial Operations stakeholders and driving business-critical decisions./liliDemonstrated ability to adapt and succeed in rapidly changing environments./li/ulpEEO 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./p/div