This is what you will do:
The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for Alexion’s commercial and investigational products. The duty includes collaborating with the global CMC/RA team, managing the team member of Japanese CMC regulatory, selecting and managing external contractors and proposing an appropriate budget plan for the successful CMC regulatory activities.
You will be responsible for:
- Independently manage and accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including compliance of clinical and commercial products.
- Plan, coordinate, and manage the development, preparation and submission of the CMC sections of Alexion’s registration dossiers and supplements (partial change application and minor change notification) for commercial products in Japan.
- Develop proactive regulatory strategies for Japan CMC product lifecycle management, with limited oversight. Present CMC strategies and plans to Alexion management and appropriate core teams.
- Effectively build and lead project teams for CMC submissions.
- Create and maintain detailed project plans to ensure clarity of deliverables and timing through the use of project management tools and principles.
- Constantly monitor and evaluate GRA-CMC team's progress towards meeting milestones and timelines, through active communication and review of pertinent information.
- Identify and monitor critical path activities and develop contingency plans.
- Publish clear and concise meeting agendas, minutes, and action items. Track action items through to completion.
- Provide feedback to management of project progress / scope changes / risks and impact to timelines.
- Drive timely decisions, and facilitate active communication and information flow between team members, senior management and impacted sites / functional areas.
- Research and provide interpretive analyses of regulatory guidance documents, regulations, or directives that impact CMC for Japan. Operates independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems.
- Prepare responses to Japanese Health Authorities’ questions and comments; prepare briefing packages as assigned. Interfaces directly with Japanese Health Authorities in order to discuss and define regulatory applications. May act as CMC representative in formal meetings and teleconferences with Japanese Health Authorities.
- Work closely with representatives of Regulatory Affairs including Japanese regulatory leads, Manufacturing, Technical Services, Process Development, Quality, Supply Chain and other key partners both internal and external to the company. Provide guidance and expertise on assigned RA-CMC documents/projects.
- Ensure that the quality and content of CMC documentation is complete and complies with applicable regulations and regulatory/scientific guidelines and in accordance with Alexion’s strategic initiatives and policies.
- Ensure that appropriate CMC documentation is filed and archived in designated systems.
- Ensure the quality of local GMP documentations and conduct GMP related activities for investigational medicinal product.
You will need to have:
- Relevant technical experience in biopharmaceutical or related experience in a scientific discipline with additional technical / project education or training; with a minimum of 5 years of experience in Regulatory and/or, Regulatory-CMC. Other relevant experience in the pharmaceutical industry, for example in (Bio)Pharmaceutical or Analytical Development, Quality Control, Manufacture, also considered.
- Education: Bachelor’s degree in relevant scientific discipline.
- Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment.
- Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.
Date Posted
05-6月-2026
Closing Date
03-6月-2027
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
