Senior Regulatory Operations Associate

Position Summary:

The Senior Regulatory Administrator (SRA) provides essential administration and operational support to the Regulatory Affairs department overseeing the efficient management and maintenance of regulatory documents within the regulatory systems. This role is pivotal for ensuring that regulatory documentation is accurate compliant and submitted in a timely manner to regulatory bodies such as the FDA EMA and other international authorities. The SRA supports the department by managing the organization of regulatory documents for submissions ensuring compliance with relevant guidelines and regulations. The SRA involves in optimizing processes mentor team members and collaborating across departments to enhance our regulatory operational

Essential functions of the job include but are not limited to:

• Upload organize and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS) FDA eGateway Common European Submissions Platform (CESP) etc.).
• Coordinate the redaction of confidential and proprietary information in regulatory documents ensuring compliance with global standards.
• Liaise with external vendors for document redaction services and track the progress of redaction processes.
• Assist in preparing formatting and completeness checking documents for regulatory submissions (e.g. FDA EMA and other global regulatory authorities).
• Support the creation of regulatory submission packages ensuring adherence to technical guidelines as advised by Regulatory Manager
• Provide publishing and technical support for submission documents including conversion to compliant formats (e.g. PDF eCTD).
• Assist under the guidance of Regulatory Manager in auditing and reviewing regulatory submissions for accuracy completeness and adherence to submission standards.
• Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team.
• Maintain uptodate tracking logs for submission timelines regulatory approvals and document status.
• Assist with internal audits and inspections by preparing required regulatory documentation and facilitating communication between stakeholders.
• Mentor train and supervise junior Regulatory Administrators by providing guidance and support.
• Resolve complex issues related to submission document upload publishing and system functionality.
• Contribute to planning and process improvement to enhance regulatory operation.
• Collaborate with cross functional teams.
• Participate in department meetings to stay informed of regulatory updates project timelines and submission requirements.
• Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies.

Qualifications:

Minimum Required:

• Bachelors degree or equivalent experience
• Computer literacy (MS Office/ Office 365)
• Fluent in English both written and verbal.
• 3 years in document management

Preferred:

• Previous experience in clinical research regulatory affairs or a related field particularly within a CRO pharmaceutical or biotech company.
• Advanced knowledge of CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR).
• Previous Knowledge compiling and publishing including eCTD.
• Understanding of global regulatory requirements and guidelines including FDA EMA and other regulatory bodies.
• Experience with document management systems (e.g. eTMF Veeva Vault MasterControl) and electronic submission formats (eCTD).

Competencies

• Strong attention to detail and accuracy in handling regulatory documents.
• Excellent organizational and time management skills with the ability to prioritize tasks and meet deadlines.
• Excellent communication and interpersonal skills capable of interacting with internal teams and external stakeholders.
• Ability to work as part of a team
• Proven ability to resolve complex technical issues efficiently.
• Significant knowledge of regulatory submission processes and guidelines including FDA EMA ICH and CTR requirements.
• Adaptability to work in a fastpaced evolving regulatory environment.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status or other characteristics protected by law.

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