Regulatory Operations Associate

Position Summary: 

The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to 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 RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations.

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).
• Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team.
• Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status.
• 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:

• Bachelor’s degree, or equivalent experience,
• Computer literacy (MS Office/ Office 365)
• Fluent in English, both written and verbal.
• 1-2 years’ experience in document management

Preferred:

• Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company.
• Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR).
• 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.
• Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders.
• Ability to work as part of a team, with a proactive approach to problem-solving.
• Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements.
• Adaptability to work in a fast-paced, 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. 

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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