Marketed Product Regulatory & CMC Manger
YOUR TASKS AND RESPONSIBILITIES:
- Oversight and 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
- Conduct comprehensive risk assessments and develop CMC strategies for assigned products. under collaboration with the team to drive project success
- Engage in effective communication and/or negotiation with counterparts, e.x. global regulatory affairs, product supply, external supplier, and health authorities to secure approvals for assigned products. Build trust and foster open dialogue and collaborative problem-solving
- Mentor less-experienced colleague in developing expertise by advising regulatory processes, change assessments and CMC regulatory strategies
WHO YOU ARE:
- University degree or above
- 5+ years-experience in areas of regulatory CMC and change management of marketed products
- In-depth understanding of regulatory requirements, difference from overseas regulation and processes related to CMC submissions, including familiarity with health authority interactions
- Sufficient experience in regulatory tasks to handle various 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 as a CMC specialist about one of specialized area in CMC, 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
- 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
- Excellent verbal and written communication skills, with the ability to engage effectively with stakeholders in Japanese / English (TOEIC 700 or more)
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
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