Manager - Product Regulatory
Date: 22 Jul 2024
Location: Petaling Jaya
Company: Shiseido
OUR MISSION: BEAUTY INNOVATIONS FOR A BETTER WORLD
We believe beauty inspires hope and empowers happiness, contributing to a world of wellness and a lifetime of fulfilment for all things living. Since our founding, we have expanded the possibilities of beauty through innovations to discover and create new value. With the power of beauty, we strive to create a better, more sustainable world for all.
POSITION SUMMARY
As a Product Regulatory Manager, your primary responsibility is to ensure that the Companys products comply with all relevant regulations and standards while leading the regulatory team. You will oversee the regulatory approval process, coordinate with government agencies, manage compliance risks, and develop regulatory strategies.
Your role involves conducting research, maintaining documentation, and collaborating with cross-functional teams to achieve product compliance and market access. Additionally, you will mentor and guide your team to ensure effective regulatory operations.
KEY RESPONSIBILITIES
Regulatory Compliance and Strategy
Oversee the entire product compliance and registration process, ensuring compliance with local regulations and requirements in Malaysia
Manage the end-to-end process of product registration, from initial submission to obtaining local registration approval, ensuring timely completion and adherence to regulatory deadlines
Work closely with the Regional Regulatory Affairs to provide updates on local regulation and requirements in Malaysia
Coordinate with cross-functional teams, including Demand and Supply Planners, Brand Team, and other stakeholders, to ensure alignment and compliance with local regulations and standards
Act as the primary point of contact for inquiries related to product compliance from internal teams and external regulatory bodies, providing timely and accurate information as needed
Collaborate with the Brand Team to localize product packaging and labelling materials to ensure compliance with local regulatory requirements and standards
Review and approve packaging materials to ensure they meet regulatory specifications, including language, warnings, and product information
Maintain comprehensive documentation of all product compliance activities, including registration approvals and correspondence
Generate regular reports on the status of product registrations, compliance metrics, and key performance indicators for management review
Govern and monitor the product quality requirement as per Group standards
Lead the mock product recall process and ensure readiness for actual recalls
Government Liaison
Lead interactions with regulatory agencies to facilitate product approvals, answer inquiries, and address compliance issues
Prepare for and participate in regulatory audits and inspections required by government agencies
Develop strong relationships with regulatory bodies and industry associations
Team Leadership and Development
Manage and mentor the regulatory team, providing guidance and support
Develop training programs to enhance the regulatory knowledge and skills of the team
Set clear objectives and performance expectations for the regulatory team
Foster a collaborative and productive team environment
Risk Management and Assessment
Conduct comprehensive assessments of potential product safety and compliance risks
Develop and implement strategies to identify and mitigate potential compliance risks and issues
Lead risk management initiatives and ensure proactive measures are in place
KEY PERFORMANCE INDICATORS (KPI)
To be determined by the positions reporting manager with the following factors also be taken into consideration as part of the roles KPI:
Direct Influence:
Compliance and risk management
Market access
Documentation and records
Indirect Influence:
Cost savings and optimization
Brand reputation and market competitiveness
Other measures of success but are not limited to:
Positive stakeholder feedback management, peers
Achievement of all deadlines
Adherence to all procedures and policies
KNOWLEDGE, SKILLS, AND EXPERIENCE
A bachelors degree in science, major in chemistry, or a related field is preferable
Minimum 5 years of working experience in product regulatory roles, with at least 2 years in a managerial position
Familiarity with Control of Drugs and Cosmetic Regulations and GDP
Excellent communication and interpersonal skills
Strong attention to detail and accuracy in handling documentation and record keeping
Good organizational and time management skills
Proficiency in MS Office applications, particularly Microsoft Excel
Leadership and team management experience
Strategic thinking and problem-solving abilities
Job Segment: Compliance, Regulatory Affairs, Law, Risk Management, Manager, Legal, Finance, Management
