Job Description

MilliporeSigma is looking for Senior Specialist - Regulatory Submission Management to join our dynamic team and embark on a rewarding career journey. Regulatory Compliance : Ensure that all regulatory submissions adhere to the relevant local and international regulations, guidelines, and requirements. Submission Planning : Develop and implement submission plans for various regulatory applications, including new drug applications, marketing authorization applications, and clinical trial applications. Document Preparation : Oversee the compilation and preparation of regulatory documents, including clinical trial data, safety reports, manufacturing details, labeling, and other relevant information. Quality Control : Conduct thorough quality checks to verify the accuracy and completeness of all regulatory documents before submission. Submission Tracking : Maintain a comprehensive database or tracking system to monitor the status of all regulatory submissions, ensuring timely and successful submissions. Communication : Liaise with cross-functional teams, regulatory affairs personnel, and other stakeholders to gather necessary information and resolve any submission-related issues. Electronic Submission : Ensure that all submissions are compliant with electronic submission requirements and format them according to health authorities' specifications. Regulatory Intelligence : Stay updated with changes in regulatory guidelines and requirements, keeping the organization informed about potential impacts on submissions. Regulatory Agency Interactions : Collaborate with regulatory agencies during the submission process, responding to queries, and providing requested information. Risk Management : Identify potential risks or challenges related to submissions and develop strategies to address them effectively.