Were seeking a highly motivated, self-driven, and enthusiastic Regulatory Affairs writer to join our Regulatory Affairs Team. At RemeGen, our regulatory affairs group is responsible for drafting and reviewing eCTD modules (including nonclinical and clinical) for submission of US FDA and EMA. This role requires you to interact across all the development functions of RemeGen. This role is based at our site in Rockville/MD.
Write and review eCTD modules (including nonclinical and clinical), ensure CMC dossiers meeting ICH format and content requirements, as well as specific local requirements of individual countries.
Build and manage relationships through active partnering with key internal and external cross-functional stakeholders, which include process development, analytical development, manufacturing, quality control and quality assurance.
Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global applications.
Stay current with regulatory requirements and initiate process improvements as appropriate.
Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment