Associate Director/Senior Manager, Regulatory Affairs (Operations)
Associate Director/Senior Manager, Regulatory Affairs (Operations)
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 Associate Director/Senior Manager of Regulatory Affairs (Operations) will coordinate and manage regulatory submissions, publishing activities, and submission archiving.
This individual will have an understanding of FDA regulations and experience with the life cycle of regulatory submissions for example annual reports, post approval supplements, INDs, international clinical trial applications (CTAs), or marketing applications in electronic Common Technical Document (eCTD) format. Excellent written and effective verbal communication skills, proficiency in project management, and flexibility/adaptability to work in a fast-paced environment are also essential.
Your Role:
- Manage, and maintain regulatory submissions (e.g., INDs, CTAs, IMPDs, protocols and amendments, safety reports, DSURs, annual reports to INDs, meeting packages, FDA correspondence, etc.) in accordance with applicable regulations and Allakos information management systems.
- Maintain processes for regulatory submission document formatting, working with external publishing vendors, and transmittal to regulatory agencies.
- Manage contractual relationships and workstreams with external publishing vendors for building submissions in the eCTD structure and filing the output via the ESG (Electronic Submissions Gateway).
- Serve as primary point of contact for electronic document management and publishing systems
- Partner with Regulatory program leads and project teams in creating timelines for activities related to the preparation and publishing of regulatory submissions.
- Maintain the Allakos regulatory submission calendar and other internal trackers, provide status updates, and ensuring that stakeholders have the most recent versions for their reference.
- Provide advice from an Operation's perspective across all projects on the acceptability of regulatory submission and publishing timelines in regard to coordination of internal and external resources and vendors
- Contribute to internal process improvements that impact on Regulatory department operational functions.
- Communicate current and emerging publishing and routine reporting regulatory requirements to stakeholder groups within Allakos (US and international).
- Advise on and direct the evaluation, selection, and implementation of technology, systems, and tools related to submission planning, publishing, assembly, and archiving.
- May provide support in software validation/migration/updates specific to systems in Regulatory Affairs (e.g., implementation of regulatory information management system [RIMS])
- Update Regulatory Affairs SOPs to ensure that they reflect current regulatory authority requirements. Consult on the development and revision of SOPs from other groups (e.g., Clinical Operations) to ensure consistency in processes and procedures for documents destined for regulatory submissions.
- Develop and maintain document templates (e.g., eCTD content and structure per ICH guidelines) and internal style guides for documents to be submitted in regulatory filings.
- Manage Regulatory Operations staff (internal and external).
Qualifications and Expertise:
- Bachelor's degree in a scientific discipline or 3-6 years of regulatory documentation and operations experience, including experience in project coordination and document management systems and processes.
- Experience with pharmaceutical regulatory submissions (specifically, eCTD) and supporting regulatory filings, such as annual reports, post-approval supplements, IND/CTA or BLA/MAA.
- Understanding of FDA regulations, ICH guidance, and the drug development process.
- Advanced skills in MS Word, Excel, PowerPoint, and Adobe Acrobat.
- Familiarity with eCTD publishing software.
- Experience with RIMS for archiving (e.g., Veeva Vault RIM or similar) is an asset.
- Understanding of best practices for regulatory filing architectures; ability to create and manage an accessible and reliable system for regulatory document retrieval and archiving.
- Demonstrate strong initiative and drive. Must be organized, highly collaborative, and able to problem-solve and anticipate departmental needs.
- Strong interpersonal and communication skills. Ability to work successfully in cross-functional teams.
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.