Senior Regulatory Operations Specialist
Senior Regulatory Operations SpecialistAllakos 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:The Senior Regulatory Operations Specialist, Regulatory Affairs will assist with preparing regulatory submissions and other regulatory documents.
- Format documents including IND/BLA sections, protocols, amendments, investigator brochures, meeting packages, and IMPD, etc. for regulatory submissions.
- Generate and maintain submission Table of Contents/Timelines. Collaborate with Regulatory personnel to ensure document quality and timeliness. Coordinate document review and comment adjudication.
- Assist document authors with template use, formatting functions, and/or other document issues.
- Identify, assess, and resolve or escalate any risks or issues that could affect the successful completion of regulatory submissions.
- Review data/reports to be included in regulatory filings to assure submission-readiness.
- Coordinate with the external publishing vendor to generate CTD submissions and review the output to ensure accuracy.
- Review current and emerging regulatory requirements (e.g., US and international regulations and guidelines) that affect submissions and documentation.
- Revise document templates and style guide, as needed.
- Assist with maintaining regulatory administrative records (submission calendars, regulatory correspondence logs, investigator documentation lists, literature files, etc.).
- Participate in testing and implementing new systems and tools to improve regulatory documentation processes.
- Participate in interactions with regulatory agencies and external service providers, as applicable.
Qualifications and Expertise:
- Bachelor’s degree in a related field (technical writing or scientific discipline)
- Must have excellent attention to detail (naming conventions, consistency in content and format across multiple documents).
- Clear understanding of FDA regulations and guidance documents related to electronic submissions including the eCTD structure, Word templates and styles.
- Expertise in Word and Acrobat.
- 5 + years of IND, CTA, and/or NDA/BLA regulatory submission experience.
- 5+ years of experience in formatting documents for electronic publishing and excellent familiarity with the CTD structure.
- Excellent formatting skills in Acrobat and Word as well as proficiency with Excel. Experience with PowerPoint and Project a plus.
- Effective communication skills and flexibility to work in a fast-paced environment are essential.
- Regulatory Affairs Certification and submission experience with marketing applications (BLA/MAA) a plus.