POSITION SUMMARY
As a Product Regulatory Manager, your primary responsibility is to ensure that the Company’s 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
Additional Responsibilities
- Support in reports generation for SCM team as required
KNOWLEDGE, SKILLS, AND EXPERIENCE
- A bachelor’s 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
