Associate Director/Director Regulatory CMC
Associate Director/Director Regulatory CMCAllakos 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.
Position Summary:As a member of the Allakos team you will have the opportunity to create and manage the development of the CMC content of submissions to world-wide regulatory applications (eg, IND, CTA, BLA, MAA, and associated amendments).
- Write sections of IND, BLA, and meeting request background documents.
- Ensure applications meet Allakos’ high standard and timelines for submissions to health authorities.
- Represent the regulatory CMC function on assigned teams
- In partnership with Regulatory management, develop regulatory CMC strategy on complex issues, identify potential development problems, propose mitigation strategies, and effectively resolve issues when they occur.
- Assist in managing submission/regulatory information trackers for assigned programs.
- Assist in coordination of regulatory CMC agency meetings and preparation of meeting materials.
- Maintain awareness of changes in the regulatory space.
Qualifications and Expertise:
- BA/BS or equivalent education and 8+ years of Pharmaceutical Development and Regulatory Affairs experience or equivalent training/experience (MS with 6 years and Ph.D. /Pharm D with 3 years). A minimum of 2 yrs CMC regulatory experience is desirable.
- Combination drug product development/CMC regulatory experience is desirable.
- Excellent communication skills with an ability to communicate in a clear, concise manner.
- Excellent interpersonal skills, collaborative approach essential.
- Self-motivated with a strong sense of ownership in areas of responsibility.
- Diligent, detail oriented.
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
- Personal commitment to delivering quality work on time.
- Responsive, resilient, flexible.
- Energetic, resourceful self-starter with high integrity.
- Intellectually curious, enthusiastic, and creative.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.