Lead regulatory affairs strategies ensuring compliance for pharmaceutical submissions. Collaborate with cross-functional teams and regulatory authorities for product development success.
Responsibilities
Develop and implement regulatory strategies
Coordinate due diligence and identify regulatory risks
Collaborate with regulatory authorities
Requirements
Minimum of 6 years' experience in regulatory affairs
In-depth knowledge of global regulatory requirements
Chargé d'équipe en comptabilité générale au crédit agricole à Le Mans. Gérer l'exactitude des comptes et animer l'équipe comptable en respectant les normes financières.
Lead Director overseeing Medicaid compliance and external audits for CVS Health. Managing external regulatory audits and compliance communications with state Medicaid agencies.
Consultant Regulatory Affairs supporting medicinal product registrations in EU and UK. Managing compliance documentation, communicating with Regulatory Authorities, and updating product information.
Senior Manager in Regulation Best Interest Program overseeing business transformation initiatives and managing teams across multiple locations in the United States.
Senior Consultant leading quality management and IT projects in manufacturing. Overseeing IT system validation, audits, and ensuring effective collaboration in compliance and quality management.
Business Services Specialist executing and supporting operational excellence across Argentina, Chile, and Peru in a biopharmaceutical company. Collaborating with teams to enhance compliant execution and business efficiency.
Compliance Manager leading compliance initiatives at Medisca, a global healthcare solutions provider. Ensuring regulatory adherence and overseeing vendor programs across multiple jurisdictions.
Director of IT Governance, Risk & Compliance at Zentalis Pharmaceuticals developing GRC strategies. Leading compliance for FDA regulations in a clinical - stage biotech environment.
Licensing Compliance Officer for the City of Hamilton ensuring by - law compliance and conducting inspections. Engaging with the community and liaising with businesses for adherence to regulations.