Director/Associate Director, Regulatory Affairs
Description
The position is responsible for supporting and leading activities within Regulatory Affairs department, to support clinical development of oncology products at ORIC. This involves working closely with cross-functional colleagues including regulatory operations, quality, CMC, nonclinical and clinical team members. S/he will be a highly motivated team player with the ability to plan proactively, work independently, think strategically and execute assigned projects effectively.
Essential duties and responsibilities:
- Support regulatory submission and strategic direction for all ORIC’s development programs.
- Lead to deliver high quality and timely regulatory submissions in alignment with corporate goals, and in compliance with all applicable regulatory requirements.
- Coordinate and collaborate regulatory activities across functions within ORIC, ie, regulatory operations, quality, CMC, nonclinical, clinical.
- Responsible for the creation, assembly, review and/or oversight of complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution.
- Ensure consistency, completeness and adherence to standards for all regulatory submissions.
- Represent ORIC to develop and maintain strong relationships with the FDA and other global regulatory agencies.
- Grow corporate, project and industry knowledge by reviewing and analyzing current regulatory issues, guidance, initiatives and communicating regulatory intelligence internally.
- Participate in providing strategic input on regulatory activities in support of product development plan.
- Participate in the development and review of standard operating procedures to ensure compliance with current regulatory requirements.
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Education and Experience:
- Bachelor’s degree in a scientific or related field, advanced degree preferred.
- At least 8+ years of regulatory affairs experience for the associate director or 10+ years of Regulatory affairs experience for the director in the pharmaceutical or biotechnology industry
- Experience in preparing regulatory submissions, eg, IND, DSUR, CTA, FDA meeting request.
- Demonstration of excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
- Excellent writing and editorial skills, ability to collaborate on development of high-quality clinical-regulatory documents, eg, investigator brochures, meeting request/package.
- Strong organizational skills, with the ability to manage multiple projects simultaneously and meet deadlines.
- Strong attention to details with accuracy and quality
- A good scientific background and understanding with the ability to acquire therapy area and regulatory knowledge.
- Knowledgeable in global regulatory requirements and guidelines (eg, FDA guidance, ICH) and gathering regulatory
- Position will be commensurate with experience
The anticipated salary range for candidates who will work in our San Diego location is between $150,000- $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title 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.