Regulatory Affairs Manager CH Japan

Regulatory Affairs Manager CH Japan

YOUR TASKS AND RESPONSIBILITIES:

• Determine local regulatory strategies and manage operational tasks to fulfill the local business strategies for the CH portfolio, in coordination with local functions and with close coordination with CH Regional Head and other global regulatory units. Ensures transparent, timely and efficient communication with business, supply chain and other local- regional-global functions, providing regulatory expertise to achieve common goals. Effectively manages priorities for CH portfolio

• Develop and assess new formulations desirable for Japanese market. Ensure formulation development, manufacturing and control of food supplements/nutrients that leads to successful launch of new products
  • Determine local product development strategies by fulfilling product target profiles and local regulations
  • Manage external partners (contract development and manufacturing organizations, contract manufacturing organizations, and/or contract research organizations) by providing regulatory input to ensure formulation, raw materials,, manufacturing processes, analytical methods, feasibility and stability samples, batch analyses and stability tests, and technical reports can fulfill local regulation
  • Contribute to achieving assigned project objectives by taking responsibility for project decisions, providing technical advice for the development team, supporting other functions to ensure optimal project / product development, discussing / agreeing priorities, timelines and quality in order to deliver the best possible formulation

• Delivers regulatory affairs milestones for Japan Consumer Health business
  • Manage new product launch of CH products
  • Prepare dossier in system, conduct review, submit new product application and obtain market authorization
  • Maintenance, update and renewal of product licenses in compliance with global standard and local regulations
  • Manage product lifecycle of CH products including CMC changes and site transfers
  • Perform regulatory assessment of changes, prepare regulatory documents for submission and obtain health authority approval (eg. Partial Amendment Application (PAA), pre-approval GMP inspection, Foreign Manufacturer Accreditation/Registration (FMA/FMR) and Minor Change Notification (MCN) according to relevant regulations and obtain approvals for implementation

• Ensure regulatory compliance:
  • Supports and implements change management activities in cooperation with other functions
  • Provides relevant information on RA milestones and archive documents submitted for incorporation into global databases. Ensure global and local registration database are updated
  • Manage the processes on supply and communication of Package Inserts (J-PI) change by closely collaborating with BU and/or Product Supply Japan
  • Create and update local label including Japanese J-PIs in accordance with local requirements and Global labelling procedure for medicinal and non-medicinal products
  • [Preferable] Contribute to GPSP (Good Post-marketing Study Practice)/GVP (Good Vigilance Practice) activities for Rx products

• Represent Bayer as a competent, reliable partner to the local Health Authorities in all regulatory matters. Proactively shape the regulatory environment in the country by participation and leadership of topics of strategic importance for Bayer.  In industry association groups create an effective network as well as proactively influencing the direction of regulatory policy in alignment with CH business objectives. Builds strong regulatory network with national regulators, local industry organizations and key opinion leaders

WHO YOU ARE:

• Pharmacy, Life Sciences or equivalent scientific degree with at least 6 years industry experience in regulatory affairs with proven track records in Consumer Health environment managing projects and resources (experience in pharmaceutical industry and in health authority interaction preferable). Proven experience in health food products (experience in ethical products, OTC drugs, quasi-drugs, and cosmetics preferable)
• Knowledge and experience in formulation and analytical development. Knowledge and experience in Japanese regulation for food/nutrient industry (incl. Japan’s Specifications and Standards for Food Additives, Food Sanitation Act, Food Labeling Act)
• Native writing and oral skills in Japanese. Good writing and oral communication skills in English
• Demonstrated cross-functional communication skills. Ability to clearly voice Bayer’s and Regulatory Affairs’ needs
• Detailed understanding of the operating procedures and policies of local health authority
• Ability to develop effective solutions to business problems, providing high degree of accuracy and reliability for regulatory feasibility

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