A Global Healthcare & Pharmaceutical Company
Our Client is one of the country’s top healthcare companies over the world with more than 160 years of experience. It was established in Vietnam in 1992 and more than 60 subsidiaries worldwide, They have been providing world-class products and services to health care professionals.
Regulatory Affairs Manager
Health/Medical Care, Pharmaceutical/Biotech - Ho Chi Minh, Ha Noi
Salary: Competitive Offer Package
The Job
Purpose of the role:
- Regulatory compliance and registration of wide range of consumer products in Vietnam
- Meeting the challenges of local regulatory environment by working through trade/industry organizations and various other external contacts to influence regulations and the company’s ability to sell and market existing/new products and technologies.
Key Responsibilities:
REGULATORY & REGISTRATION
- Advice & counsel team members and related business partners on registration/ notification regulations and regulatory compliance to support new product launches and maintain regulatory compliant raw materials & products.
- Monitor registrations activities to ensure raw material & product registration including ingredients, claims, packaging, labelling, etc. are approved on time and in accordance with required statutory & registration requirements.
- Review & evaluate new and existing products, concept/category, label and claims development, raw materials, ingredients, formulas and packaging against regulations as well as proposed regulation changes, develop proactive approaches and strategies with HQ to ensure regulatory compliance and prevent/avoid raw materials & product compliance issues.
- Develop & maintain internal processes, procedures & knowledge for registration & regulatory compliance review & implementation and & support for external audit enquiries.
- Support region for other regulatory projects or activities assigned.
REGULATORY POLICY DEVELOPMENT
- Serves as Company primary contact leading scientific & technical support, establishing sound communications and leveraging relationships with trade/ industry organizations, Associations & professional Organizations & policy makers to understand well their regulatory practices & potential directions.
- Review, monitor and identify the impact of current and developing regulations, analyze threats & opportunities, implement risk assessment, and participate in the compilation and maintenance of databases for regulations and related regulatory compliance issues.
- Work closely with Global, Region & Affiliate Business Partners to develop influencing strategies or change regulatory policies & intelligence through scientific approach in alignment with business plans and identified risks or opportunities and local legal procedures, industry standards at the assigned budget toward stated goal achievement.
- Establishes, communicates, and maintains global RPIoperational documents, templates, tools, standards, and data requirements for RPI processes and broader management systems
- Coordinates to participate in regional or global regulatory activities with associations & standardization bodies, governmental advisors and scientific cooperation partners
COMMUNICATIONS & CONSULTANCY
- Consult Manufacturing & Distribution team for Good Manufacturing Practice & Good Distribution Practice that are aligned with requirements;
- Consult Sales & Marketing team with product literature development/labelling to ensure compliance with regulations and with technical product information as required;
- Serve as Company representative to respond to Government agencies & Regulators related to technical product information areas especially for Food Supplement & Nutrition.
- Provides support with analysis and resolution of product inquires or complaints received including Product Adverse Reaction;
- Keeps current legislation updated and communicate these to region & US headquarter for understanding & knowledge transferred.
TEAM MANAGEMENT
- Consult, manage & develop high performing team members to achieve all regulatory objectives
Your Skills and Experience
- Education: BA/BS
- Degree Field: Pharmaceutical, Food Science or Health and Nutrition, Chemical or related field
- At least 5 years related Experience
- Good Technical Regulatory knowledge & practice in Vietnam market, Food/Nutrition/Cosmetics is preferred;
- Good relationship with Government agencies, Associations & Professional organizations;
- Strong interpersonal skills & influencing skills to work diversified people;
- Good strategy thinking, detailed oriented & flawless execution;
- Customer focus, Flexible to adapt with changes and lead team for high performance;
- Good collaboration & teamwork player
- Influent & effective communication
- Good English & Vietnamese in written and verbal.
- Preferred Knowledge, Skills, Abilities and/or Related Experience:
- Good manufacturing and audit knowledge/ experience wil be a good advantage
Why You'll Love Working Here
- Opportunity to work for professional working environment
- Opened professional and general management training
- Competitive salary and great benefits
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Ho Chi Minh, Ha Noi
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