Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
Relocation Assistance Offered Within Country
#93600 - Tokyo Tokyo-To Japan
Job Summary
Responsible for supporting Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development manufacturing distribution marketing and sales of Hills products in Japan. Develops creative approaches and strategies to solve regulatory problems and support Hills marketing and business initiatives.
Principal Duties and Responsibilities
%
Duty/Responsibility
20
General Regulatory leadership - advise business on compliance with applicable regulations. Provide regulatory reviews and assessments of product concepts marketing claims and strategies label copy product formulas and ingredients and advice on any issues and potential liability. Work with Associate Director Regulatory Affairs EMEA/Japan to develop regulatory strategy and priorities. Provide training to the business on the regulatory regime and enforcement environment. Use knowledge of regulatory processes and procedures to counsel clients in devising strategies to remove barriers to successful product introductions.
35
Product Label & data management:
Develop and review technical label copy based on formula recipe; review product labels/ artworks in a timely manner and assure compliance with applicable Codes Regulations and Laws.
Manage regulatory product information in Hills databases (Impira Prodigi)
Assure correctness of the regulatory information that appear on Hills website
15
Regulatory Vigilance - stay abreast of regulatory developments in Japan share information and coordinate approach with Associate Director Regulatory Affairs EMEA/Japan. Monitor changes in the regulatory environment; advise and make recommendations to management as to the impact of regulatory changes. Build foster and maintain appropriate and effective relationships with key regulatory agencies (e.g. MAFF AQS). Address and defend regulatory challenges that arise.
15
Industry Trade Associations represents Hills in the regulatory Committees and at the board level of the key trade associations in Japan. Build foster and maintain strong working relationships and influence Associations strategy and decision making on Hills behalf.
Provide regular status updates and make recommendations where appropriate.
10
Product Development Support - review product formulations and ingredient specifications for compliance in Japan. Provide timely regulatory assessments of project proposals for changes to existing products or new products.
5
Import Support - provide guidance as needed to ensure timely product imports; help resolve import matters as needed.
100
Total Percent (not to exceed 100%)
This is not an exhaustive list of duties or functions.
Education/ Experience Requirements
Basic qualifications include:
Bachelors of Science in Biology Chemistry or nutrition related field.
In-depth experience in Regulatory Affairs dealing with governmental and regulatory agencies in Japan.
10 years of experience in the feed food medical device cosmetic / consumer product veterinary product or pharmaceutical industry involved in labeling ingredients product claims and support product registrations or submissions and other regulatory related matters.
Possess thorough knowledge of local regulatory requirements relevant to responsibilities.
Preferred Qualifications
Post graduate degree in an applicable science.
Training or certification in Regulatory Affairs (e.g. RAC).
Relevant regulatory affairs experience in pet food or feed related industry.
Expected Areas of Skills/Knowledge/Abilities
Fluent in English and Japanese: proficient and advanced reading writing speaking skills.
Possess thorough knowledge of local regulatory requirements relevant to responsibilities.
Ability to evaluate and provide relevant guidance on issues that may impact Hills products.
Ability to interpret and apply relevant laws regulations guidelines that impact pet products.
Ability to educate appropriate members of the regulatory agencies and trade associations on key issues impacting Hills.
Ability to work with various departments especially marketing; understand the business perspective; and provide advice counsel and leadership to support market and business objectives.
Manage multiple simultaneous initiatives programs and projects.
Excellent communication skills including interpersonal writing presentation and analytical skills.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion gender gender identity sexual orientation national origin ethnicity age disability marital status veteran status (United States positions) or any other characteristic protected by law.
Are you interested in working for Hills Pet Nutrition You can apply online and attach all relevant documents such as a cover letter and resume or CV. Applications received by e-mail are not considered in the selection process. Become part of our team. We look forward to your application.
Work that matters fueled by passion for pets! At Hills we have a purpose. Every day around the world we transform the lives of millions of pet families through pioneering innovation amazing nutrition and the best and brightest people. Founded more than 75 years ago with an unwavering commitment to pet nutrition Hills mission is to help enrich and lengthen the special relationships between people and their pets.
HILLS Prescription Diet therapeutic pet foods HILLS Science Diet and HILLS Ideal Balance wellness pet foods are sold worldwide. Hills is a division of Colgate-Palmolive a leading global consumer products company tightly focused on Oral Care Personal Care Home Care and Pet Nutrition with sales of products in more than 200 countries. To learn more about Hills and Colgate please visit and or find us on LinkedIn Facebook Twitter and YouTube.
Reasonable accommodation during the application process is available for persons with disabilities. Please contact with the subject Accommodation Request should you require accommodation.
Required Experience:
Manager
Employment Type
Full Time
