Regulatory Affairs Manager
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Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology this role you will collaborate closely with colleagues across regulatory operations quality CMC nonclinical and clinical functions to support high-quality timely regulatory submissions. The ideal candidate is a proactive team player who thrives in cross-functional environments communicates effectively and can balance strategic thinking with strong execution.
Essential duties and responsibilities include the following. Other duties may be assigned.
- Support regulatory submissions and contribute to strategic planning for assigned programs.
- Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
- Responsible for the creation assembly review and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
- Develop manage and track regulatory submission timelines.
- Collaborate cross-functionally with regulatory operations quality CMC nonclinical clinical teams.
- Ensure submissions meet standards for accuracy completeness and consistency and maintain health authority correspondence archives.
- Review investigator packages and support site start-up activities from regulatory perspective.
- Expand knowledge by analyzing current regulatory issues guidance initiatives and effectively communicate regulatory intelligence internally.
- Contribute to the development and review of standard operating procedures to ensure regulatory compliance.
Perform all duties in keeping with the Companys core values policies and all applicable regulations.
Qualifications :
- Bachelors degree in a scientific or related field advanced degree preferred.
- Preferred minimum 6-8 years of regulatory affairs experience in the pharmaceutical or biotechnology industry or a combination of an advanced degree and regulatory experience.
- Experience in preparing regulatory submissions (eg IND DSUR CTA FDA meeting requests).
- Strong communication interpersonal and collaboration skills across internal and external stakeholders.
- Good project management skills; able to manage multiple projects simultaneously and meet deadlines.
- High attention to detail with excellent problem-solving and analytical thinking abilities.
- Excellent writing and editorial skills with the ability to develop high-quality clinical-regulatory documents (eg investigator brochures briefing documents IND amendments Fast Track/ODD designation requests).
- A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape.
- Familiarity with global regulatory requirements and guidelines (FDA ICH) with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things.
- Computer expertise including Microsoft Office Suite proficiency (eg Word Excel PowerPoint). Experience with regulatory information management system (Veeva RIM) is a plus.
Additional Information :
The anticipated salary range for candidates is between $145000-$165000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc.
ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristic.
Remote Work :
No
Employment Type :
Full-time
Key Skills
About Company
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high ... View more
