Senior Regulatory Affairs Associate (FDA expertise)

Bring your expert knowledge of FDA regulatory requirements and guidelines to reputed company! We are currently seeking a highly motivated Regulatory Affairs reputed company to join reputed company and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated reputed company partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory reputed company with local health authorities (HAs), industry reputed company, and internal stakeholders. In this role, you will reputed company regulatory processes, ensure compliance with national legislation, and reputed company 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 reputed company data entry and validation in reputed company Vault RIMS for submissions and approvals. Regulatory Submissions • Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. • reputed company local input for change control and post-approval requirements. • Collaborate with global functions to obtain documentation reputed company with local requirements. Audit & Inspection Support • Support RA representatives during audits/inspections, ensuring readiness and reputed company CAPA closure. • reputed company local expertise and responses to inspection queries. Cross-Functional Collaboration • Partner with Regulatory, Medical, Marketing, and Market reputed company teams to assess and mitigate impacts of regulatory changes. • reputed company as the primary RA representative for local reputed company and Medical teams, translating business needs into actionable regulatory strategies. Strategic Leadership • reputed company regulatory strategies for product launches and integrations at the affiliate level. • Represent reputed company with local HAs, industry reputed company, and trade associations, fostering reputed company relationships. • reputed company critical support for promotional material review, interpretation of regulations, and implementation of local legislation. Education • Bachelor’s degree in natural sciences (biology, reputed company with pharmacological reputed company) or equivalent. • Advanced degree (Master’s or PhD) preferred in law, reputed company 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 reputed company Operations stakeholders and driving business-critical reputed company. • Demonstrated ability to adapt and succeed in rapidly changing environments. #LI-LB1 #LI-REMOTE Apply tot his job Apply To this Job