Regulatory Operations Associate

As a Regulatory Administrator at our company, you will play a vital role in providing administrative and operational support to the Regulatory Affairs department to ensure the smooth facilitation of the regulatory submissions process. Your responsibilities will include: - Uploading, organizing, and maintaining regulatory documents within various regulatory authority submissions portals such as CTIS, FDA eGateway, and CESP. - Coordinating the redaction of confidential information in regulatory documents and ensuring compliance with global standards. - Collaborating with external vendors for document redaction services and monitoring the progress of redaction processes. - Assisting in preparing, formatting, and checking the completeness of documents for regulatory submissions to FDA, EMA, and other global regulatory authorities. - Supporting the creation of regulatory submission packages and ensuring adherence to technical guidelines as directed by the Regulatory Manager. - Providing publishing and technical support for submission documents, including conversion to compliant formats like PDF and eCTD. - Keeping abreast of evolving regulations, communicating updates to the Regulatory Affairs team, and maintaining tracking logs for submission timelines and document status. - Participating in department meetings to stay updated on regulatory updates, project timelines, and submission requirements. - Ensuring all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications required for this role are: - Bachelor's degree or equivalent experience. - Proficiency in MS Office/Office 365. - Fluency in English, both written and verbal. - 1-2 years of experience in document management. Preferred qualifications include previous experience in clinical research, regulatory affairs, or related fields, familiarity with the CTIS system, understanding of global regulatory requirements, experience with document management systems, and electronic submission formats. Key competencies for success in this role include attention to detail, organizational and time management skills, effective communication, teamwork, problem-solving abilities, knowledge of regulatory submission processes and guidelines, and adaptability to a fast-paced regulatory environment. Please note that all data provided as part of the application process will be handled in accordance with our Privacy Policy. If you require a reasonable accommodation or an alternative method for applying due to a disability, please contact us at QuestionForHR@precisionmedicinegrp.com. We also want to emphasize that our organization follows a formal interview process and will not extend job offers without prior communication with our recruiting team and hiring managers.,