Job Description

This role is responsible for Japan regulatory expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include Japanese registered information dossier maintenance in product’s life cycle management (MCN/PCA) based on global change control management, and preparation and compilation of J-NDA submission/documentation for specific small molecule, oligonucleotide, biologics projects and/or combination products, working with RegCMC Japan Head and key stakeholders, primary contact for CMC Regional Regulatory Lead on regulatory CMC activities in Japan and managing of routine and non-routine regional Health Authority (PMDA and MHLW) interactions as delegated by the CMC global team.

The RegCMC Japan lead is primary contact for global team on regulatory CMC activities in Japan.

This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, regulatory CMC knowledge and interpersonal skills are required.

Duties and Responsibilities:

• Providing Japanese strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
• Preparation and delivery of CMC regulatory operational plans for products in Japan and supporting the preparation and delivery of regulatory submissions.
• Responsible for submission from defining and agreeing content with CMC global team to executing reviews as required to ensure complete, concise and accurate submissions to PMDA in Japan with CMC Regional Regulatory Lead.
• Writing and / or Review of Japanese CMC submission documents and responses to PMDA questions.
• Managing CMC aspects of routine and non-routine regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
• Monitoring changes in the regulatory CMC environment in Japan to support and advise CMC global lead and teams with Regional Regulatory Lead.
• Providing input into regulatory CMC risks assessment and mitigation plans from a regional perspective for Japan and ensuring that it remains in line with the overall global regulatory CMC strategy.
• Coordinating and completing regulatory assessments of CMC changes in the designated systems.
• Responsible for supporting Regional Regulatory Lead and maintaining open lines of communication with them on assigned projects/products to ensure awareness on status and issues relating to submissions in Japan.
• Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of RegCMC on cross functional work streams
• Responsible for leading or assisting in delivery of RegCMC initiatives and the development of RegCMC standards and SOPs in Japan, as assigned.
• Ensure that appropriate records are maintained in the designated system for submission in Japan.

Key Contacts and Interactions: Ethically interacts with multiple international, cross-functional departments, industry peers and health authority contacts at all levels.

Customer focused: Interacts with a functional area key stakeholder both internally and externally, including subject matter experts, partners and regulatory agency personnel.

Qualifications

Regulatory Skills

• At least 5-7 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
• For at least two late phase development products or commercial products, interact with Global RegCMC team and relevant Biogen Japan departments with strong leadership as Japan CMC lead
• Successful authoring and contribution to delivering CMC submission documents of development and marketed products (biological, oligonucleotide, chemical entities and/or gene therapy products)
• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
• Experience of direct communication and negotiation with regulatory agencies on CMC matters
• Knowledge of GMP requirements and standard systems (e.g. change management systems)
• Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
• Leadership/Management Skills
• Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.
• Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
• Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
• Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
• Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
• Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.
• Ability to solve problems in complex environments.
• Ability to project and timeline management.
• Ability to budget planning/management.

Fluent English – spoken and written.
 

Additional Information

Preferred/Additional:

Recognized experience in project and timeline management. Inclusive/flexible mindset. Self-starter and team worker.

Education:

BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.