Senior Regulatory Affairs Manager

We are seeking an experienced 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.

• Manage the preparation and coordination of submissions to INDs or CTAs (including EU CTIS submissions and country-specific applications in regions outside the U.S.)
• Prepare and deliver high-quality and timely regulatory submissions include all required documents and are compliant with applicable regulatory requirements.
• Contribute to strategic planning for assigned programs by providing regulatory guidance on U.S. EU CTIS and country specific CTA processes
• 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 (MS PhD PharmD).
• 12 years experience with Bachelors degree -or- 8 years experience and Masters degree -or- 5 years experience and PhD/PharmD 
• Demonstrated hands-on experience with U.S. IND submissions EU CTA submissions in CTIS outside the U.S. CTA preparation and coordination and health authority interactions and response management
• Experience managing IND and CTA lifestyle activities (amendments updates and maintenance)
• Experience in preparing regulatory submissions (eg IND DSUR CTA FDA meeting requests).
• Strong communication interpersonal and collaboration skills across internal and external stakeholders.
• Strong project management skills and organization skills with ability to work independently manage multiple projects simultaneously and meet deadlines in a lean fast-paced environment.
• 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.
• Flexible proactive and hands-on mindset with a can-do attitude

Additional Information :

The anticipated salary range for candidates is between $165000-$175000 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. This position is not eligible for H-1B visa sponsorship.

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