Regulatory Affairs Manager
Kuala Lumpur - Malaysia
Job Summary
Job Location
KUALA LUMPUR GENERAL OFFICEJob Description
About the Role
Join P&G Personal Healthcare as a Regulatory Affairs Manager for Malaysia and Singapore where you will play a critical role in enabling trusted products accelerating market access and maintaining regulatory compliance across two dynamic healthcare markets. This role offers the opportunity to influence business decisions partner with regional and global teams and shape regulatory strategies that support innovation and business growth.
You will be responsible for translating local regulatory requirements into practical business solutions across product registration lifecycle management artwork and labeling compliance promotional review and regulatory risk management. Success in this role requires strong technical expertise strategic thinking disciplined execution and the ability to build effective relationships with both internal and external stakeholders.
Why Join P&G
At P&G we develop trusted brands that improve the lives of consumers around the world. We believe in empowering our employees with meaningful responsibility from Day 1 providing opportunities to lead influence decisions and grow professionally through challenging assignments and dynamic career experiences. This role provides:
- Regional and global exposure within a leading multinational organization.
- Opportunities to influence business decisions through regulatory expertise.
- Direct engagement with health authorities industry associations and key stakeholders.
- Ownership of a diverse Personal Healthcare portfolio across Malaysia and Singapore.
- A collaborative environment that values innovation leadership and continuous learning.
What Success Looks Like
In this role you will:
- Deliver timely and compliant regulatory approvals renewals variations and post-approval maintenance activities.
- Anticipate regulatory risks and translate them into clear business recommendations and mitigation strategies.
- Build trusted partnerships with health authorities distributors trade associations and internal business partners.
- Ensure regulatory compliance is embedded throughout product development artwork labeling promotional review and commercialization activities.
- Drive continuous improvement knowledge sharing and operational excellence within Regulatory Affairs.
- Demonstrate ownership sound judgment and the ability to work independently while remaining aligned with local regional and global priorities.
Key Responsibilities
Regulatory Strategy & Market Access
- Support Regulatory Affairs activities for the Malaysia and Singapore Personal Healthcare portfolio.
- Develop and execute regulatory strategies that support product registrations business continuity and portfolio growth.
- Assess emerging regulations and communicate potential impacts to business stakeholders.
- Translate regulatory requirements into clear and actionable submission and compliance plans.
Product Lifecycle Management & Compliance
- Manage regulatory submissions including new registrations variations renewals and other post-approval activities.
- Coordinate dossier preparation regulatory correspondence submission tracking and lifecycle maintenance activities.
- Ensure regulatory records documentation and archives are maintained in accordance with company and health authority requirements.
- Conduct regulatory assessments and provide guidance on product compliance matters.
Artwork Labeling & Promotional Material Compliance
- Review ingredient declarations product classifications artwork labeling packaging and promotional materials.
- Partner with cross-functional teams to ensure compliance with local regulations and company standards.
- Identify potential compliance risks and drive timely resolution.
Stakeholder Management & External Engagement
- Build effective relationships with health authorities distributors trade associations and industry stakeholders.
- Represent P&G in regulatory discussions and external engagements where appropriate.
- Support science-based advocacy initiatives that contribute to regulatory policy and industry development.
Leadership & Continuous Improvement
- Lead regulatory risk assessment and communication for key business initiatives.
- Provide clear recommendations status updates and mitigation plans to stakeholders and management.
- Champion process improvements operational excellence and knowledge-sharing initiatives.
- Contribute to a culture of ownership collaboration and continuous learning.
What We Are Looking For
We are seeking a professional who:
- Takes ownership and delivers results with excellence.
- Thrives in a fast-paced dynamic and highly regulated environment.
- Builds strong partnerships across functions and cultures.
- Simplifies complexity and translates technical regulatory requirements into practical business recommendations.
- Demonstrates strong planning prioritization and execution skills.
- Brings an external perspective and remains current with evolving regulatory trends.
- Continuously seeks opportunities to improve processes strengthen capabilities and develop others.
Location
- Malaysia (supporting both Malaysia and Singapore Personal Healthcare regulatory activities).
About P&G
P&G serves consumers around the world with one of the strongest portfolios of trusted quality brands including Always Ariel Gillette Head & Shoulders Oral-B Pampers Pantene Tampax and many more. We are committed to building an inclusive workplace where employees can contribute grow and make an impact from Day 1.
P&G is an equal opportunity employer. We value diversity and are committed to creating a workplace where everyone can succeed and thrive.
Job Qualifications
Required Qualifications
- Bachelors degree in Pharmacy
- 35 years of Regulatory Affairs experience within pharmaceutical consumer healthcare personal healthcare medical device or related regulated industries.
- Strong understanding of regulatory requirements within Malaysia and/or Singapore.
- Ability to interpret and apply regulations to product registration classification ingredients labeling artwork and lifecycle management activities.
- Strong analytical problem-solving and decision-making skills.
- Excellent written and verbal communication skills in English.
Preferred Qualifications
- Experience within a multinational or regional healthcare organization.
- Exposure to OTC products prescription medicines medical devices health supplements or related healthcare categories.
- Familiarity with Regulatory Information Management (RIM) PASS or similar regulatory systems.
- Proficiency in Bahasa Malaysia.
- Experience interacting with health authorities and managing external stakeholder relationships.
Job Schedule
Full timeJob Number
RJob Segmentation
Experienced ProfessionalsRequired Experience:
Manager
About Company
The Procter & Gamble Company is an American multi-national consumer goods corporation headquartered in downtown Cincinnati, Ohio, founded in 1837 by British American William Procter and Irish American James Gamble. It primarily specializes in a wide range of cleaning agents and person ... View more