ãConsumerã Regulatory Affairs Associate Manager
ãConsumerã Regulatory Affairs Associate Manager
Posted on :
22-08-2025
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1 Vacancy
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Job Description
ConsumerRegulatoryAffairs Associate Manager (Senior Specialist)
Division: Regulatory Affairs Johnson & Johnson Company
PositionTitle: Associate Manager
Position Summary
- Develop and flawlessly execute regulatorystrategies to the Japan Consumer might include but is not limited to new productdevelopment/introduction life cycle management due diligence preparation ofregulatory submissions to PMDA/Tokyo for registration of new productsingredients changes to marketed products;
- Help develop and approve innovative claimsfor products;
- Participate in key industry associations(JSMI ACCJ etc.) capture and share industry trends represents JnJsposition to shape regulatory environment for consumers health;
- Liaise with Government Affairs and helpdevelop and execute external engagement strategies.
- OTC/ Quasi-drug/ Band Aid/Skin Health -portfolios assigned will be decided based on the background of candidate andbusiness need
Key Responsibilities
- Ensure timely and efficient registration fornew products and product compliance for existing registrations. Prepareapplications for registration of new products and variations to marketedproducts and rescheduling application as required and maintain regulatorydocumentation and databases in line with J&J procedures.
- Critically analyze and provide regulatorystrategy for data packages and ingredients for regulatory compliance or newproducts and identify discrepancies in data presented and request additionaldata.
- Assist in the development of labelling anddevelop product information in accordance with relevant regulations and codes.
- Suggest and implement improvements toprocesses and procedures to make the department more efficient.
- Build and maintain strong business partnerrelationships and attend Project Team meetings as required to ensure timely andaccurate communication on projects. Provide cross functional support for otherbusiness areas as required.
- Develop and maintain strong relationshipswith government officials and industry associations through attendance atmeetings conferences and seminars as appropriate to ensure compliance withthe regulations information sharing and influence is optimized in relation toindividual product portfolios.
- Identify review and disseminate informationto relevant company personnel to ensure awareness and compliance with newregulations/codes and their subsequent amendments through the Regulatory Radarprocess.
- Maintain adequate product knowledge to ensureprompt and professional responses to queries relating to company and provide Regulatory Affairs approval of advertising and promotionalmaterials ensuring accuracy and compliance with codes of conduct. IncludeMedical Affairs when appropriate when developing new claims.
- Work with Manager by means of performancereview system to define own strengths weaknesses and aspirations and to planactivities that will benefit own development and companys objectives. Assistin training and development of junior staff in the department when required.
Requirements
The following personal attributes are essential:
- Build strong Trust relationship with all relevant collaborators and key stakeholders
- Demonstrate Agility to manage difficult situations and complex projects
- Has strong sense of Ownership in her/his job position
- Familiar with domestic and international regulations (OTC quasi-drug medical device skin care)
- Business-oriented and solutions-oriented mindset
- Ability to effectively communicate both regulatory/technical (product science) requirements and input to business partners
- Ability to succeed as an individual contributor but is also seen as a key team player with strong interpersonal skills with the ability to relate to a wide variety of levels cross-functional teams and to make contribution in the achievement of common goals
- Strong communication (oral & written) facilitation and presentation skills in both Japanese and English
Degree/Professional Experience:
Degree of Pharmacy Chemistry Life science
As Associate Manager at least 3-5 years experience in Regulatory Affairs
English:
At least lower Business level English required (Speaking reading writing. TOEIC Score 700 or above
Japanese:
Native or high business level is required
PC skill:
Excel / Word / e-mail / PowerPoint
Required Experience:
Manager
Employment Type
Full Time
Department / Functional Area
Key Skills
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