R&D Marketed Product Regulatory & CMC Manager

Job description

R&D Marketed Product Regulatory & CMC Manager YOUR TASKS AND RESPONSIBILITIES:

• Lead regulatory CMC activities, including Partial Amendment Applications (PAA), pre-approval GMP/QMS inspections, Foreign Manufacturer Accreditation/Registration (FMA/FMR), Marketing Authorization (MA) Notifications, and Minor Change Notifications (MCN) .
• Prepare and review submission documents for assigned products including NDA/PAA/MCN, ensuring alignment with customer needs and regulatory requirements.
• Independently assess Japan-specific CMC regulatory risks, develop feasible regulatory options and mitigation plans, and recommend an appropriate strategy for assigned products.
• Engage in effective communication and/or negotiation with global functions, product supply, external supplier, and health authorities to secure approvals for assigned products. Build trust and foster open dialogue and collaborative problem-solving.
• Support the development of less-experienced colleagues by providing guidance on regulatory processes, change assessments and CMC regulatory strategies.

WHO YOU ARE

• University degree or above
• 3+ years of experience in areas of regulatory CMC and change management of marketed products
• Strong understanding of differences between Japanese and global regulatory requirements and processes related to CMC submissions, including familiarity with health authority interactions
• Hands-on experience assessing and implementing a range of post-approval CMC changes
• Proven experience of CMC documentation for submission with excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions
• Solid technical background, knowledge and understanding in at least one CMC technical discipline, e.g. chemistry, formulation, analytical science, or quality assurance
• Ability to prioritize regulatory change management within complex situations influenced by multiple factors, and provide guidance to efficiently execute regulatory change management
• Ability to explain Japan CMC regulatory requirements, risks and recommendations in English and effectively collaborate with global stakeholders to achieve alignment on strategies and actions.
• A proactive, creative mindset that embraces change and drives innovation within the team
• Ability to establish rapport with all key stakeholders with VACC leadership mindset
• Fluency in Japanese and business level English is preferred (TOEIC 700 and above as a guide)

WHAT BAYER CAN OFFER YOU

We offer a competitive a salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at Bayer

We provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your manager We support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participations At Bayer, our employees are welcomed, supported, and encouraged to reach their full potential.

We also embrace and respect diversity by providing an inclusive and fair work environment for all employees We provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance Date of Employment: ASAP Division: Pharmaceuticals Location: Tokyo / Osaka Functional Area: Regulatory Affairs Position Grade: E13-VS1.1 Employment Type: Regular Work Time: 09:00 - 17:30 Contact Us E-Mail [email protected]