Senior Regulatory Operations Specialist, Regulatory Affairs

Company: Allakos, Inc.
Location: Redwood City
Posted on: January 15, 2022

Job Description:

Senior Regulatory Operations Specialist, 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. Position Summary: The Senior Document Publishing Specialist, Regulatory Affairs, will assist with preparing regulatory submissions and other regulatory documents. This individual will have a clear understanding of electronic submission requirements including the eCTD structure, Word templates and styles, and at least 5-- -years of IND, CTA, and/or NDA/BLA regulatory submission experience. Effective communication skills, expertise in Word and Acrobat, and flexibility to work in a fast-paced environment are essential. Responsibilities: Format Word documents that include IND/BLA sections, protocols and amendments, investigator brochures, meeting packages, IMPD, reports, etc. for regulatory submissions in accordance with document templates and internal style guide and applicable electronic publishing requirements. Generate and maintain submission Table of Contents/Timelines. Collaborate with Regulatory personnel to ensure document quality and timeliness and coordinate document review and comment adjudication, as needed. Assist document authors with template use, formatting functions, and/or other document issues, as needed. Identify, assess, and resolve or escalate, if needed, 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 of PDF files. 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, as needed. Participate in interactions with regulatory agencies and external service providers, as applicable. Qualifications: 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. At least 5 years of experience with formatting Word documents and Acrobat PDF files 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. Regulatory Affairs Certification and submission experience with marketing applications (BLA/MAA) a plus. The salary is competitive and commensurate with experience and qualifications. -- - 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.

Keywords: Allakos, Inc., Redwood City , Senior Regulatory Operations Specialist, Regulatory Affairs, Other , Redwood City, California