Regulatory Operations Associate
Regulatory Operations Associate
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 uptodate 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:
- Bachelors degree or equivalent experience
- Computer literacy (MS Office/ Office 365)
- Fluent in English both written and verbal.
- 12 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 problemsolving.
- Knowledge of regulatory submission processes and guidelines including FDA EMA ICH and CTR requirements.
- Adaptability to work in a fastpaced evolving regulatory environment
Any data provided as a part of this application will be stored in accordance with ourPrivacy CA applicants please also refer to ourCA Privacy Notice.
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 .
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team hiring managers and a formal interview process.
Required Experience:
IC
Employment Type
Full Time
