Manager, Regulatory Affairs - Risk Management

Shiseido•East Windsor, NJ

21d•Hybrid

About The Position

The Manager, Regulatory Risk Management, oversees and manages regulatory risk within Shiseido Americas. The role conducts regulatory analyses, interprets applicable regulations, and communicates practical insights, assessments, and recommendations to business stakeholders. It supports compliance strategies and processes to help ensure adherence to relevant requirements, identify and mitigate risks, and respond to evolving regulations while supporting reliable, business-focused regulatory outcomes and operational performance. The position monitors regulatory changes and technical risks affecting cosmetics, ingredients and fragrances, packaging, and tools in the United States, Canada, Brazil, and other Latin American countries. It assesses risks, advises senior leadership, supports robust product development, and works with execution departments and cross-functional teams to confirm regulatory compliance within deadlines. The role also establishes and updates workflows, timelines, databases, systems, and SOPs; supports regulatory audits and investigations; and promotes collaboration among regions on quality risks, recalls, and audits. The manager leads and develops regulatory affairs professionals, expatriates, and global trainees through guidance, education, training, and mentorship. The role also supports employee engagement by analyzing Global Employee Engagement Survey results, setting goals, and addressing areas for improvement. Additional duties may be assigned to support the organization's vision, mission, and values.

Requirements

BS or MS in Chemistry or a related field.
At least 6 years of regulatory affairs experience and demonstrated technical expertise.
At least 3 years of team leader experience and strong people management skills.
Demonstrated communication skills to convey information and enable actionable business steps.
Analytical skills to gather global regulatory information and translate it into usable information and decision-making data.
Strong project management skills to manage timelines for multiple product launch and reformulation projects.
Knowledge of cosmetics and OTC formulation, raw materials, and packaging.
Goal-oriented, proactive, able to multitask, and strongly organized.
Ability to collaborate and communicate in a multicultural environment.
Ability to work independently and motivate a team.
Flexible, customer-oriented, and results-oriented.
Ability to perform under pressure on short-timeline or concurrent projects and complete work in a timely manner.
Knowledge of industry trends and a valuable external network.
Fluency in written and spoken English.

Responsibilities

Develop and manage regulatory risk strategies to ensure compliance with applicable regulations and guidelines.
Monitor and interpret regulatory changes and technical risks affecting Shiseido businesses in the United States, Canada, Brazil, and other Latin American countries, including legislation relating to cosmetics, ingredients and fragrances, chemical substances, packaging, and tools.
Conduct risk assessments, identify potential regulatory issues, and develop mitigation strategies.
Advise senior leadership on risks, opportunities, and compliance strategies.
Provide regulatory expertise and thought leadership to support robust product development.
Coordinate with execution departments to meet regulatory deadlines and confirm compliance; raise system issues and work with cross-functional teams to establish appropriate mechanisms.
Establish and update workflows, timelines, databases, and systems to meet new requirements; update and implement SOPs.
Collaborate with internal and external stakeholders to support alignment with local and global regulations.
Communicate regulatory information and updates to senior management and internal teams in a timely and effective manner.
Oversee and participate in regulatory audits and investigations, and address findings or concerns with effective solutions.
Promote regional collaboration on quality risk cases, product recalls, and audits.
Manage and develop regulatory affairs professionals, expatriates, and global trainees through guidance, education, training, and mentorship.
Analyze Global Employee Engagement Survey results, set goals, identify improvement areas, address employee concerns, and champion workplace engagement.
Use available managerial resources for career coaching, compliance training, policies and procedures, performance management, learning and development, Trust 8, engagement, and well-being.