Director/ Sr. Director, Regulatory Affairs
Director/ Sr. Director, Regulatory Affairs
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.
Allakos is committed to developing innovative therapies that transform patients' lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Your Role:
- Leads, implements, and executes regulatory strategy (Clinical, Non-clinical, CMC) and global submission plans for early and/or late stage projects.
- As a strategic member of project teams across multiple indications and programs, designs and develops regulatory (clinical, non-clinical and CMC) strategic options
- Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans
- Serves as corporate regulatory liaison with regulatory Health Authority (HA) to develop effective professional relationships as well as a positive company image.
- Effectively leads focused meetings with HA to ensure full discussion of issues and opportunities.
- Leads and/or participates in regulatory and technical and clinical operation initiatives to establish and improve processes and ways of working, keeping current with approaches to regulatory strategy, dossier strategy, and submissions.
- May supervise Regulatory Affairs team members.
- Proactively partners with the leaders within clinical, non-clinical and CMC on the development of the regulatory and overall program development strategies.
- Independently executes preparation of regulatory documentation including authoring and/or reviewing and maintenance of initial applications, routine amendments, responses to information requests, meeting background materials/scientific advice to support interactions with HAs, annual reports, IND safety reports/DSURs, and correspondence with HAs
- Leads cross-functional team discussions and works to gather consensus (e.g., leads adjudication meetings of regulatory submission documents such as HA briefing documents/scientific advice and meeting requests)
- Maintains strong relationships with cross-functional internal colleagues, and between regulatory team and regulatory agencies, external CROs, regulatory consulting groups, and other third parties. Participates in cross-functional teams, providing regulatory feedback and support
- Maintains up-to-date working knowledge of current FDA, EMA, MHRA and Ex-US regulations and guidelines as well as familiar with global regulatory environment. Proactively assesses and communicates impact, potential risks, and potential mitigations.
- Prepares and delivers effective presentations for external and internal audiences
- In conjunction with Regulatory Operations, develops processes and utilizes tools for creating, maintaining, tracking, and communicating regulatory submission and publishing plans, and timelines to internal stakeholders and external vendors
Qualifications and Expertise:
- Bachelor's degree required. Advanced degree in life sciences strongly preferred.
- Average of 10-12 years or equivalent relevant experience in regulatory affairs with primary expertise in Clinical and secondarily in CMC.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
- Strong regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, eCTD structure, lifecycle management, leading interactions with HAs, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
- Experience in interpretation of regulations and guidelines
- Broad strategic skillset, including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., competitive landscape, challenging therapeutic areas).
- Skilled in influencing, partnership, and collaboration, including demonstrated ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Foster effective, positive interactions with cross-functional stakeholders and corporate partners
- Excellent written and verbal communication skills
- Strong ability to prioritize workload
- Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
- Able to prospectively identify potential problems and to partner effectively and positively to solve issues
- Successful in taking a program from early to late stage and/or BLA
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.