Regulatory Affairs intern supporting compilation of Annual Reports and PADERs at Cosette Pharmaceuticals. Engaging with experienced professionals in a collaborative, learning environment.
Responsibilities
Learn content and format of Annual Reports and compile Annual Reports for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
Learn content and format of PADERs and compile PADERs for NDAs and ANDAs
Create and review Labels and Patient Information
Learn Electronic Common Technical Document (eCTD) software and compile submissions
Requirements
Experience with MS Word and PDF
Ability to learn new software
Currently pursuing a bachelor’s degree in chemistry, pharmacy, regulatory science or related discipline.
Managing Environmental Permitting Lead at Anchor QEA leading waterfront development projects. Responsible for permitting strategies and regulatory approvals in the San Francisco Bay Area and beyond.
Associate for managing relationships with clients requiring FATCA/CRS compliance. Conducting documentation review and maintaining client portfolios while supporting team processes.
Regulatory Affairs Manager handling drug approval processes and regulatory affairs. Working with authorities and ensuring compliance for a leading international pharmaceutical firm in Munich.
Referent in Organisationsentwicklung and Governance supporting compliance and development at Diakonie Mark - Ruhr. Involved in building internal controls and quality frameworks in a social organization.
Lead compliance and AML efforts at Onafriq, a fintech company, overseeing FCA regulations. Act as MLRO ensuring robust compliance culture while supporting UK business growth.
Vendor Compliance Analyst coordinating Oracle solutions and troubleshooting customer scorecards at Helen of Troy. Collaborating with internal teams to ensure compliance and address issues efficiently.
Product Development & Regulatory Specialist in an innovative nutricosmetic company. Supporting product innovation and regulatory compliance for collagen - based supplements in global markets.
Director of Compliance leading compliance initiatives across the US Commercial organization at Organon. Implementing tools and processes to drive compliance and risk management initiatives.
GRC Analyst responsible for assessing vendor security risk and compliance for SysLogic. Strengthening third - party risk management program aligned with regulatory and industry standards.