What are the responsibilities and job description for the Regulatory Operations Specialist position at Proclinical Staffing?
Proclinical Staffing is a specialist employment agency providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
We are seeking a Senior Publisher/Regulatory Operations Specialist to join our team. This role involves shaping regulatory strategies and ensuring seamless submissions in a dynamic environment. The ideal candidate will manage complex documentation workflows, uphold quality standards, and collaborate with cross-functional teams to enhance efficiency.
The successful candidate will have expertise in electronic submissions and regulatory requirements, including proficiency in IND/BLA/eCTD and other electronic submission guidelines. They will also have a background in Chemistry or Life Sciences, experience with DocuBridge software, and familiarity with the pharmaceutical industry and regulatory affairs.
Key responsibilities include managing and overseeing complex documentation workflows, maintaining high-quality standards in all regulatory submissions, collaborating with cross-functional teams, navigating and implementing electronic submission processes, and ensuring compliance with regulatory requirements and guidelines.
