Senior Manager, Regulatory Affairs (CMC)
Senior Manager, Regulatory Affairs (CMC)
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:
As a member of the Allakos team you will be responsible for developing CMC regulatory strategies and create and manage the development of the CMC content of electronic Common Technical Document (eCTD) Module 2.3 and Module 3 of global regulatory applications (e.g., IND/IMPD, CTA, BLA, MAA, and associated amendments).
Your Role:
- Participate as Regulatory CMC Lead on teams and represent CMC Regulatory Affairs in cross-functional team discussions by providing regulatory expertise and input to product development plans.
- Develop and execute CMC regulatory strategies for one or more monoclonal antibody products in the Allakos pipeline.
- Lead the preparation of CMC content for submission to Health Authorities (HAs). May involve writing (or oversight of technical writing by external vendors) Module 2.3 and Module 3 of the IND/IMPD, BLA/MAA, responses to information requests, and meeting background materials/scientific advice documents to support meetings with HAs.
- 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 coordination of regulatory CMC agency meetings and preparation of meeting materials.
- Maintain awareness of changes in the regulatory space to ensure compliance with global regulatory requirements, regional guidance, and HA expectations over the life cycle of a product.
- Provide accurate regulatory impact assessments of CMC changes to teams/projects and ensure that changes are reported to HAs in accordance with regulatory requirements.
- In conjunction with Regulatory Leads and Regulatory Operations, assist in creating and managing CMC submission plans, timelines, and regulatory information trackers for assigned programs.
- Leads cross-functional team discussions and works to gather consensus (e.g., leads adjudication meetings of regulatory submission documents such as IND/IMPD CMC sections or responses to information requests)
- Develops and manages relationships with internal and external partners and vendors and maintains effective ways of working.
- Contributes to development and implementation of business processes and tools within the Regulatory and CMC teams.
- Performs critical review of technical CMC documentation such as validation master plans, standard operating procedures, validation protocols and reports, comparability reports, product specifications and other documents used for drafting Module 3 and that are subject to inspection by HAs.
Qualifications and Expertise:
- BA/BS or equivalent education in biological, pharmaceutical, chemical, or engineering sciences with 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 years CMC regulatory experience in biologics (e.g., monoclonal antibodies) is required.
- Knowledge of EU and FDA regulations required.
- Experience in CMC dossier strategy and life cycle management.
- Combination product development is an asset.
- Excellent written and verbal communication skills with an ability to communicate in a clear, concise manner.
- Strong presentation skills.
- Advanced skills in MS Word, Excel, and PowerPoint.
- Excellent interpersonal skills, collaborative approach essential.
- Self-motivated with a strong sense of ownership in areas of responsibility.
- Diligent, detail oriented critical thinker with the ability to problem solve.
- Must be able to work on multiple projects simultaneously, work independently, 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.
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.