Director, Regulatory Affairs
Company: Equillium, Inc.
Position: Director, Regulatory Affairs
Location: San Diego or South San Francisco
Posted: February 24, 2021
Equillium (www.equilliumbio.com) is a clinical stage biotech company (NASDAQ:EQ) focused on developing novel therapies for severe and life threatening autoimmune and inflammatory diseases. Its lead program, EQ001, is a first-in-class anti-CD6 mAb that targets a novel co-stimulatory pathway involved in the activation, proliferation, differentiation and trafficking of T effector cells in autoimmune and inflammatory diseases. Equillium is currently initiating a number of early phase proof of concept clinical studies including studies in GVHD and Asthma. As Equillium advances EQ001, it is also considering expanding clinical development into other potential autoimmune indications including indications such as multiple sclerosis, inflammatory bowel diseases, and lupus.
Overview of Position:
The Regulatory Affairs Director serves as the Regulatory Lead for development projects while managing, reviewing, planning and preparing complex regulatory submission documents for global regulatory filings. Among other responsibilities, the Director will interpret regulations, and provide regulatory guidance to project teams. The Director drives regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives as well as provides regulatory affairs perspective to project teams and other functions. Lastly, the Director supports management with development and implementation of departmental strategies and policies.
Essential Duties & Responsibilities:
- Represent regulatory in cross-functional teams and provide functional teams with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration.
- Develop and execute regulatory strategies to ensure (nonclinical, clinical, CMC) development plans are comprehensive and comply with regulatory requirements for marketing applications.
- Coordinate the preparation, review and execution of regulatory submissions (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).
- Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
- Effectively plan, organize, and conduct formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
- Maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on the development programs.
- Interact and manage external vendors and proactively resolve issues related to outsourced regulatory activities.
- Responsible for communication of submissions and approvals to relevant cross functional teams.
- Ensure archiving of regulatory documents (eg, submissions, internal memos, key correspondence).
- Plan, develop and write Standard Operating Procedures (SOP) to support the Regulatory Department activities. Interact with Company personnel to implement SOPs.
- Provide input into critical metrics and management reports.
- Proactively seeks out and recommends process improvements.
- Other regulatory activities as assigned.
Education and Experience:
- Bachelor's degree in scientific discipline is required. A Master’s degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable.
- 10 years of regulatory experience; OR a Master’s degree, or JD with a minimum of 7 years of regulatory experience in regulatory strategy development.
- Managing and coordinating regulatory submissions (IND, NDA/BLA, amendments, supplements, annual reports, etc).
- Preparation and coordination of CTA submissions.
- Experience in biologics is a plus.
Skills and Attributes:
- Ability to understand scientific and health principles related to product development and regulations.
- Attention to detail.
- Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment.
- Experience in successfully managing the operations of domestic and international clinical trials.
- Proven ability to manage multiple tasks and associated deadlines
- Exceptional communication (oral and written) and interpersonal skills
- Strong computer literacy, including Microsoft Office suite
- Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
Equal Opportunity Employer