Director/Associate Director, Regulatory Operations
Description
The Director will be responsible for overseeing the planning, coordination, and execution of regulatory strategies and day-to-day operations as we transition to registration-focused and commercial activities. This leadership role requires expertise in global regulatory submission processes, strategic project management, and cross-functional collaboration with various departments including clinical development, manufacturing, and commercial teams. Coordinate with Regulatory Affairs on regulatory deadlines providing support for regulatory document publishing and electronic Common Technical Document (eCTD) structure.
Essential duties and responsibilities include the following. Other duties may be assigned.
- Lead the regulatory operations function to ensure the successful preparation, submission, and approval of regulatory filings for late-stage clinical programs, including Investigational New Drug (IND), New Drug Application (NDA), Biological License Application (BLA), and other registration-related submissions globally.
- Partner closely with regulatory affairs, clinical development, quality assurance, and manufacturing teams to ensure alignment on timelines, resources, and requirements for late-stage regulatory submissions and market approvals.
- Act as a liaison between the regulatory team and other departments to ensure smooth communication and coordination of submission timelines and deliverables. Monitor regulatory submission status, providing timely updates to leadership and key stakeholders
- Oversee and manage the regulatory submission process, ensuring all filings are in compliance with applicable regulations, deadlines, and quality standards. Maintain a robust submission schedule and ensure timely delivery of documents, data, and other regulatory materials to regulatory authorities.
- Stay current with evolving global regulatory requirements and guidance documents. Provide strategic input on regulatory pathways and address potential risks to the timely approval of products.
- Identify opportunities to streamline regulatory operations processes and implement best practices, tools, and technologies to improve efficiency, quality, and compliance. Ensure that regulatory documents are maintained in accordance with internal SOPs and external regulatory requirements.
- Represent the company during regulatory agency meetings, inspections, and audits as required. Respond to agency queries and work with relevant stakeholders to resolve any issues related to regulatory submissions.
- Develop and manage budgets for the regulatory operations department, ensuring the efficient allocation of resources. Monitor ongoing projects to ensure the department’s financial and operational goals are met.
- Refine regulatory submission processes to improve efficiency and compliance, ensuring that systems are in place to track submissions, approvals, and status updates. Support regulatory operations in due diligence activities as required
- Oversee maintenance and continuous improvement of regulatory operations systems, tools, and templates
Build, lead, and mentor a team of regulatory operations professionals. Foster a culture of collaboration.
Experience:
- Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree (MS, PhD, or MBA) preferred.
- Minimum of 12-15 years of experience in regulatory affairs, with at least 5 years in a leadership role managing regulatory operations within the pharmaceutical industry.
- Deep understanding of global regulatory requirements, submission processes, and regulatory agency expectations (FDA, EMA, ICH, etc.).
- Strong knowledge of regulatory submission systems (eg, Veeva Vault QMS, eCTD, CTD, publishing software) and document management.
- Familiarity with project management methodologies and tools.
- Strong leadership and management skills, with the ability to inspire, motivate, and mentor teams.
- Excellent communication skills, both written and verbal, with the ability to effectively collaborate with internal teams, senior leadership, and external regulatory authorities.
- Excellent interpersonal skills, with the ability to build effective relationships with internal and external stakeholders.
Ability to think strategically while balancing regulatory needs with business objectives.
The anticipated salary range for director level candidates is between $210,000-$240,000 and associate director level candidates is between $160,000-$190,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC is a multi-state employee, and this salary range may not reflect positions that work in other states.
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.