Director, Regulatory Affairs

At ACELYRIN, INC. the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency.  Our key value of courageous caring means putting patients first and having the courage needed to quickly solve challenging issues. We strive to redefine what is possible and quickly bring innovative therapies to bear against serious diseases.

Location: Agoura Hills, California            

Job Title: Director, Regulatory Affairs      

Reports To: Executive Director, Regulatory Affairs            

Function: Regulatory Affairs      

Job Type: Full time         

Position Summary:

The Director of Regulatory Affairs will support the development & execution of global regulatory strategies for one or more products. This individual assures that regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs. They will support the day-to-day regulatory activities of assigned products, identify, and gather data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed to meet relevant global regulatory requirements. Additionally, they will manage regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Responsibilities:

• Responsible for one or more product(s) with limited oversight and supports the Senior Director Regulatory Affairs in the development & execution of global regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.

• Serve as the primary contact for FDA and EMA on assigned products.

• Lead and be a key contributor responsible for the planning, preparation, and coordination of regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs/CTAs, PIP/iPSP, orphan drug designation (ODD) requests, breakthrough therapy designation (BTD) requests, expedited pathway requests, BLAs/NDAs/MAAs, amendments, annual reports, meeting requests, briefing documents, responses to Agency queries, etc.

• Lead the triage and preparation of, and contribute to, the content of responses to queries from health authorities for assigned products, collaborating with subject matter experts as necessary, and assuring complete and timely response to health authorities during application review.

• Manage and track regulatory queries and commitments, providing periodic status updates regarding unfulfilled conditions/commitments.

• Close collaboration with internal and external cross-functional team members to ensure achievement of submissions and timely approvals of applications.

• Provide regulatory advice and guidance to enable study-level decision-making and to ensure compliance with global regulations.

• Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with cross-functional team.

• Propose approaches to resolve regulatory issues and appropriately drive speed to patients.

• Lead and/or support global health authority interactions by preparing objectives for meeting, outline of briefing material, facilitating content discussions, and gathering input from cross-functional SMEs.

• Contribute to building a strong and trusted relationship with Regulatory Agencies.

• Responsible for tracking, compiling, and maintaining the regulatory archive.

• Facilitate development of a Target Product Label and initial prescribing information for assigned products.

• Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.

• Maintain up-to-date knowledge and understanding of global regulatory requirements.

• Research and assemble regulatory intelligence to support regulatory strategy, including the assessment of regulations, regulatory precedence, and guidance documents.

• Communicate pertinent regulatory information, program updates and risks in appropriate cross-functional forums.

• Interact efficiently and independently with consultants and vendors.

• May assist in the development of process documents and/or training of staff members.

• Other duties as assigned.

• Domestic or international travel may be required (eg, to attend health authority meetings).

Qualifications and Skills Required:

• Required skill set:

  • Proven skill at developing and implementing successful US and EU regulatory strategies.
  • Experience in the preparation and maintenance of global regulatory documents/dossiers (eg, INDs/CTAs, PIP/iPSP, orphan drug designation (ODD) requests, breakthrough therapy designation (BTD) requests, expedited pathway requests, amendments, annual reports, BLAs/NDAs/MAAs, meeting requests, briefing documents, responses to Agency queries, etc.).
  • Experience leading interactions with FDA and EMA.
  • Comprehensive knowledge and understanding of FDA, EMA, ICH, GxP regulations, guidance documents and practices.
  • Experience in biologics drug development.
  • Strategic and analytical thinker with excellent problem-solving skills.
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences.
  • Excellent organizational skills and attention-to-detail.
  • Able to work independently and complete projects with minimal oversight, escalating issues to regulatory management with discretion.
  • Exceptional interpersonal skills and the proven ability to work collaboratively and efficiently with cross functional team members, management, and external vendors, to meet company goals.
  • Self-starter and results-oriented individual with outstanding work ethic; must be able to perform in a fast-paced environment.
  • Ability to multi-task and adjust priorities quickly while working under tight deadlines.
  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
  • Experience using electronic document management systems and document review tools.

• Preferred skill set:

  • Working knowledge of Japan, Canada and other international markets regulations, guidance documents and practices.
  • Proven skill at developing and implementing successful Japan and other international regulatory strategies.
  • Experience leading interactions with other health authorities (eg, PMDA, Health Canada, etc).
  • Experience in orphan/rare disease product development.
  • Experience in combination product development.
  • Experience interacting with external vendors in the management of regulatory activities.
  • Experience in writing process documents/SOPs.

• Required Education: Bachelor’s degree in the biological or health related sciences required.

• Preferred Education: Advanced Degree (MS, PharmD or PhD) in a relevant scientific discipline; Regulatory Certification.

• Required Experience: 8+ years of relevant regulatory experience.

• Preferred Experience: 8+ years of relevant regulatory experience in the inflammation and/or ophthalmology therapeutic area.

Essential behaviors and ways of working:

• Commitment to company values and culture.

• Ethical, trustworthy, and reliable.

• Team player and open to the ideas of the team.

ACELYRIN, INC., does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.  Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.