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Offers “Merckgroup”

days ago Merckgroup

Regulatory Expert Japan, Food & Beverage Testing Regulatory Surveillance & Advocacy/ LS

  • Internship
  • Tokyo, JAPAN
  • Accounting / Management control

Job description



Regulatory Expert Japan, Food & Beverage Testing Regulatory Surveillance & Advocacy/ LS

English follows

職務内容:

食品、飲料に関する品質試験(特に微生物・物理化学試験)にかかわる規制の理解及び動向の調査、関連業界活動のサポート業務をご担当頂きます。

積極的に関連業界活動へ参加し、監督官庁・関連業界団体への弊社の存在感を増大する。規制/ガイドライン/法改正対応サポート、とりまとめ。それら改正への当社製品の対応。関連ライセンスの管理。社内外の規制関連トレーニング。顧客からの規制に関する問い合わせのコンサルティング。関連海外支社からの法規制情報入手、報告。



求める経験・スキル:

· 食品、飲料、微生物学、化学分析、生命科学、または関連する科学のバックグラウンド、関連業界での8年以上の経験。
· 飲食料品試験に関連する規制の専門知識。食品分析検査、食品添加物に関する知識。食品の微生物学的、物理的および化学的試験の規制動向に精通。
· ビジネスレベル英語(読み書き必須)。外資系の会社での業務経験あれば尚可。
· 新しい分野に積極的に根気よく取り組める。コミュニケーションを大切に出来る。自ら学ぶ姿勢を持てる。自分自身のスキルアップのために努力を惜しまない。

必須知識:

· 微生物学専門知識
· 食品および飲料の食品安全性試験の専門知識
· 食品分析検査に関する知識
· 食品添加物に関する知識
· 日本の食品および飲料の試験と食品添加物の規制に関する深い知識
· ビジネスレベル英語



Location: Tokyo, Japan



The candidate will be a key regulatory expert for Life Science division. The candidate should have an understanding of regulations relevant to Food & Beverage testing. In addition, the candidate must be well-versed in regulatory trends for microbiological, physical and chemical testing for food & beverage, aligned with the strategy of Life Science to build regulatory expertise relevant to food safety.



Key Job Responsibilities:

· Take active role to build regulatory intelligence in Japan. Focus on Food & Beverage regulation, especially microbiological, physical and chemical testing for food and food contact materials.
· Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations.
· Safeguard Life Science strategic interests and objectives in arising guidance, standards and regulation regarding food & beverage testing.
· Responsible to meet license / compliance requirement for relevant products in food & beverage areas
· Monitor and report on changes of relevant regulatory and compliance environment with impact with Life Science business in testing area. Analyze available regulatory and compliance information.
· Increases the influence of the company in important Japanese regulatory bodies and industry associations.
· Actively participates and represents Life Science in relevant industry associations.
· Effective coordination of strategic activities of Life Science subject matter experts in regulatory bodies and industry associations.
· Secure flow of information from/to authorities, industry associations and Life Science division.
· Builds and keeps personal relationships to authorities.
· Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards.
· Deliver regulatory training & support microbiology programs for government officials, academics & industry professionals.
· Regulatory training for and support of internal stakeholders, external customers and relevant regulatory bodies.
· Provide relevant training to educate Life Science Japan commercials about new regulatory trends and developments that drive our value proposition.
· Definition of processes to implement upcoming regulatory needs and requirements.
· Support regulatory expertise and consultation for customer regulatory inquiries.
· Proactively identify and communicate areas for operational and quality/regulatory improvement.
· Provide decision support on a wide scope of operational and strategic matters impacting the achievement of the business's and function's objectives. Oversees Japanese regulatory requirements for LS portfolio in conjunction with the Business and Operations.
· Develops and documents standard processes, focus on implementing harmonized global processes.
· Closely work with Life Science global regulatory surveillance & advocacy team and regulatory subject matter experts to link the local/regional advocacy activities with global advocacy activities.
· Monitor competitor approach regarding regulatory requirements.



Education and Languages:

· Master / Ph.D. in food & beverage, microbiology, chemical analysis, life sciences or related science background.
· Native level in Japanese, Fluent in English (verbal and written) is required.



Professional Skills and Experiences:

· Minimum of 8 years of relevant industry experience, regulatory & government affairs, quality assurance/control experience related to food & beverage, microbiological & chemical analysis.
· Knowledgeable of food regulations and regulatory landscape of other important country/regions (Japan)
· Knowledge/experience of food regulations/standard regarding microbiological testing, physical & chemical testing, pesticides/heavy metals residual testing, ISO standards, food contact materials, other regulatory and compliance requirements.
· Experience of working in industry associations, standard organization, testing institutes and government bodies for industry guidelines/standard/regulation drafting, revision, comment and discussion of above mentioned area.
· Experience working in a global, matrix environment.



Personal Skills and Competencies:

· Experience in a highly matrixed, cross functional and regional environment.
· Capable of working independently.
· Strong organizational and time management skills.
· Out of the box thinking approach
· Good project management skills.
· Ability to train and educate others.
· Effective management by influence.
· Experience in thought leadership.
· Ability to work in multi-cultural teams.
· Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
· Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
· Ability to indirectly influence other organizations and cultures.
· Proficient in MS Office Software (Word, Excel, PowerPoint, Project).





Job Requisition ID: 204637

Location: Tokyo

Career Level: E - Professional (10+ years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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