Regulatory Affairs Manager CH Japan

Osaka, Japan

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Welcome to Bayer, a global leader in the healthcare industry! We are currently seeking a highly skilled Regulatory Affairs Manager to join our team in Japan. As the Regulatory Affairs Manager, you will play a crucial role in ensuring our products comply with all applicable regulations and guidelines. Your expertise will be essential in driving the success of our business and ultimately, improving the lives of patients. If you have a passion for regulatory affairs and a desire to make a meaningful impact, we invite you to apply for this exciting opportunity.

Develop and maintain a deep understanding of all relevant regulations and guidelines in the healthcare industry in Japan.
Oversee the regulatory approval process for all Bayer products, ensuring timely submissions and approvals.
Collaborate with cross-functional teams to gather necessary information and documentation for regulatory submissions.
Conduct thorough reviews of product labeling, packaging, and promotional materials to ensure compliance with regulations.
Stay up-to-date on changes in regulations and proactively communicate any potential impacts to the business.
Serve as the main point of contact for regulatory agencies in Japan, representing Bayer in a professional and knowledgeable manner.
Lead and mentor a team of regulatory affairs professionals, providing guidance and support as needed.
Participate in the development and implementation of regulatory strategies for new products and product changes.
Conduct internal audits to ensure compliance with regulations and Bayer's internal policies.
Communicate regulatory updates and changes to relevant stakeholders within the organization.
Monitor and analyze competitor activities and regulatory trends to identify potential opportunities or challenges for Bayer.
Maintain accurate and organized records of all regulatory submissions and approvals.
Identify and implement process improvements to streamline regulatory processes and increase efficiency.
Collaborate with global regulatory teams to align strategies and share best practices.
Uphold Bayer's values and standards of conduct in all interactions and decision-making.

Where is this job?

This job is located at Osaka, Japan

Job Qualifications

Bachelor's Or Master's Degree In A Relevant Field Such As Pharmacy, Biology, Or Chemistry.
At Least 5 Years Of Experience In A Regulatory Affairs Role In The Pharmaceutical Industry, Preferably In Japan.
In-Depth Knowledge Of Japanese Pharmaceutical Regulations And Guidelines, Including Drug Approval Processes, Labeling Requirements, And Post-Marketing Surveillance.
Strong Communication And Negotiation Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And External Stakeholders.
Fluency In Japanese And English, Both Written And Verbal, To Effectively Communicate With Local Authorities And Global Teams.

Required Skills

Quality Assurance
Risk assessment
Regulatory compliance
Clinical Trials
Product Registration
Regulatory Strategy
Pharmaceutical Law
Medical Device Regulations
International Regulations
Labeling Regulations
Market Authorization

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving

Additional Information

Bayer is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesJapanese

Job PostedMay 1st, 2025

Apply BeforeMay 31st, 2025

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