Regulatory Affairs Assistant Manager
CÔNG TY FINE TODAY
Địa điểm làm việc: Hồ Chí Minh
Hết hạn: 13/12/2024
- Chi tiết công việc
- Giới thiệu công ty
Thu nhập: Thoả thuận
Loại hình: Toàn thời gian
Chức vụ: Nhân viên
Kinh nghiệm: 4 năm
Mô tả công việc
Towards the Vietnam Affiliate - Ensuring Regulatory Compliance:
- Product Registration and Notification:
Guide the affiliate through the process of registering cosmetic products with the Vietnamese Ministry of Health (MoH), ensuring compliance with labeling, ingredient restrictions, and safety assessments.
Manage product notifications for lower-risk cosmetic products, adhering to specific requirements and timelines.
Successfully register products with the MoH, meeting all requirements for ingredients, labeling, safety assessments, and documentation.
- Compliance Monitoring: Continuously monitor and adapt to evolving Vietnamese regulations, ensuring ongoing compliance for existing and new products.
- Labeling and Claims Compliance:
Ensure product labels and claims comply with Vietnamese regulations, including accurate ingredient listings, usage instructions, and restrictions.
Advise on permissible claims and ensure marketing materials align with regulatory guidelines.
- Import/Export Compliance: Coordinate with SCM team to manage the import and export of personal care products, ensuring compliance with customs regulations, labeling requirements, and necessary permits.
- GMP and Quality Standards: Have best practice knowledge and oversee compliance with Good Manufacturing Practices (GMP) for locally manufactured or imported products, ensuring quality and safety standards are met.
- Post-Market Surveillance:
Establish a system for monitoring product safety and consumer feedback in the Vietnamese market.
Report any adverse events or complaints to the MoH as required.
- Local Stakeholder Engagement:
Build relationships with relevant authorities, industry associations, and consumer protection agencies in Vietnam.
Stay informed about regulatory updates and participate in industry discussions.
Advertising and Claims: Be in charge of Advertising license, superlative advertisement submission, ensure all marketing materials and product claims comply with Vietnamese regulations, preventing misleading or unsubstantiated claims
2. Towards Company's Regional/Global Management:
- Strategy Alignment:
Ensure alignment between the affiliate's regulatory activities and the company's regional/global regulatory strategies.
Contribute local insights to the development of global product formulations, labeling, and claims strategies.
Balancing Local and Global Needs: effectively balance the sometimes-conflicting demands of local regulations and global strategies.
- Regulatory Intelligence:
Provide updates on changes in Vietnamese regulations impacting the personal care industry, including new legislation, guidelines, and enforcement trends.
Analyze the impact of these changes on the company's product portfolio and market strategies.
- Information Relay:
Keep regional/global teams informed about changes in Vietnamese regulations, potential impacts on the company's products, and proposed strategies for adaptation.
Provide timely updates on the status of regulatory submissions and approvals in Vietnam.
- Data and Intelligence:
Gather and analyze data on the Vietnamese market, including competitor activities, regulatory trends, and market access opportunities.
Share this information with regional/global teams to support decision-making and strategic planning.
- Harmonization Efforts:
Identify opportunities to harmonize product registrations and labeling across different ASEAN markets, reducing regulatory burden and streamlining operations.
- Product Registration and Notification:
Guide the affiliate through the process of registering cosmetic products with the Vietnamese Ministry of Health (MoH), ensuring compliance with labeling, ingredient restrictions, and safety assessments.
Manage product notifications for lower-risk cosmetic products, adhering to specific requirements and timelines.
Successfully register products with the MoH, meeting all requirements for ingredients, labeling, safety assessments, and documentation.
- Compliance Monitoring: Continuously monitor and adapt to evolving Vietnamese regulations, ensuring ongoing compliance for existing and new products.
- Labeling and Claims Compliance:
Ensure product labels and claims comply with Vietnamese regulations, including accurate ingredient listings, usage instructions, and restrictions.
Advise on permissible claims and ensure marketing materials align with regulatory guidelines.
- Import/Export Compliance: Coordinate with SCM team to manage the import and export of personal care products, ensuring compliance with customs regulations, labeling requirements, and necessary permits.
- GMP and Quality Standards: Have best practice knowledge and oversee compliance with Good Manufacturing Practices (GMP) for locally manufactured or imported products, ensuring quality and safety standards are met.
- Post-Market Surveillance:
Establish a system for monitoring product safety and consumer feedback in the Vietnamese market.
Report any adverse events or complaints to the MoH as required.
- Local Stakeholder Engagement:
Build relationships with relevant authorities, industry associations, and consumer protection agencies in Vietnam.
Stay informed about regulatory updates and participate in industry discussions.
Advertising and Claims: Be in charge of Advertising license, superlative advertisement submission, ensure all marketing materials and product claims comply with Vietnamese regulations, preventing misleading or unsubstantiated claims
2. Towards Company's Regional/Global Management:
- Strategy Alignment:
Ensure alignment between the affiliate's regulatory activities and the company's regional/global regulatory strategies.
Contribute local insights to the development of global product formulations, labeling, and claims strategies.
Balancing Local and Global Needs: effectively balance the sometimes-conflicting demands of local regulations and global strategies.
- Regulatory Intelligence:
Provide updates on changes in Vietnamese regulations impacting the personal care industry, including new legislation, guidelines, and enforcement trends.
Analyze the impact of these changes on the company's product portfolio and market strategies.
- Information Relay:
Keep regional/global teams informed about changes in Vietnamese regulations, potential impacts on the company's products, and proposed strategies for adaptation.
Provide timely updates on the status of regulatory submissions and approvals in Vietnam.
- Data and Intelligence:
Gather and analyze data on the Vietnamese market, including competitor activities, regulatory trends, and market access opportunities.
Share this information with regional/global teams to support decision-making and strategic planning.
- Harmonization Efforts:
Identify opportunities to harmonize product registrations and labeling across different ASEAN markets, reducing regulatory burden and streamlining operations.
Yêu cầu
1. Education and Experience:
Bachelor's Degree: A bachelor's degree in a relevant scientific field (pharmacy, chemistry, biology, etc.) is still essential.
Experience: 4+ years of experience in similar position, demonstrates strong potential and a willingness to learn.
Multifaceted Experience: Experience in various aspects of regulatory affairs, including product registration, labeling compliance, import/export procedures, and quality management, is highly valued.
2. Knowledge and Skills:
Regulatory Foundation: A solid understanding of Vietnamese regulations for personal care products is crucial, even if the depth of knowledge might be less specialized than in a larger company.
Adaptability: Being able to quickly learn and adapt to new regulations and challenges is essential in a dynamic environment.
Hands-on Approach: A willingness to be involved in all aspects of regulatory affairs, from dossier preparation to stakeholder communication, is expected.
Resourcefulness: Ability to find solutions and navigate challenges with limited resources is important in a smaller setting.
Communication and Collaboration: Strong communication and interpersonal skills are vital for building relationships with authorities and collaborating with cross-functions team.
3. Personal Attributes:
Proactive and Independent: Taking initiative and working independently.
Entrepreneurial Mindset: A proactive and solution-oriented mindset, with a willingness to contribute to the company's growth.
Flexibility and Adaptability: Adapting to changing priorities and taking on new responsibilities as needed.
Strong Work Ethic: A commitment to delivering high-quality work and meeting deadlines in a fast-paced environment.
4. Language Proficiency:
Vietnamese: Fluency in Vietnamese is essential for effective communication with local authorities and stakeholders.
English: A good command of English is required for accessing international resources and communicating with potential overseas partners.
Bachelor's Degree: A bachelor's degree in a relevant scientific field (pharmacy, chemistry, biology, etc.) is still essential.
Experience: 4+ years of experience in similar position, demonstrates strong potential and a willingness to learn.
Multifaceted Experience: Experience in various aspects of regulatory affairs, including product registration, labeling compliance, import/export procedures, and quality management, is highly valued.
2. Knowledge and Skills:
Regulatory Foundation: A solid understanding of Vietnamese regulations for personal care products is crucial, even if the depth of knowledge might be less specialized than in a larger company.
Adaptability: Being able to quickly learn and adapt to new regulations and challenges is essential in a dynamic environment.
Hands-on Approach: A willingness to be involved in all aspects of regulatory affairs, from dossier preparation to stakeholder communication, is expected.
Resourcefulness: Ability to find solutions and navigate challenges with limited resources is important in a smaller setting.
Communication and Collaboration: Strong communication and interpersonal skills are vital for building relationships with authorities and collaborating with cross-functions team.
3. Personal Attributes:
Proactive and Independent: Taking initiative and working independently.
Entrepreneurial Mindset: A proactive and solution-oriented mindset, with a willingness to contribute to the company's growth.
Flexibility and Adaptability: Adapting to changing priorities and taking on new responsibilities as needed.
Strong Work Ethic: A commitment to delivering high-quality work and meeting deadlines in a fast-paced environment.
4. Language Proficiency:
Vietnamese: Fluency in Vietnamese is essential for effective communication with local authorities and stakeholders.
English: A good command of English is required for accessing international resources and communicating with potential overseas partners.
Quyền lợi
Attractive compensation & benefits;
13th month salary bonus and yearly performance bonus;
14 paid days off per year + 05 day sick leave full paid;
Health care insurance;
Great allowances (lunch, parking, phone, birthday, happy hours....);
Salary review at least one time per year based on employee's performance and contribution;
Work with experienced & strong team;
Friendly, dynamic & flexible working environments.
13th month salary bonus and yearly performance bonus;
14 paid days off per year + 05 day sick leave full paid;
Health care insurance;
Great allowances (lunch, parking, phone, birthday, happy hours....);
Salary review at least one time per year based on employee's performance and contribution;
Work with experienced & strong team;
Friendly, dynamic & flexible working environments.
Thông tin khác
Địa điểm làm việc
- Hồ Chí Minh: 25th Floor E.Town Central, 11 Doan Van Bo, Dist 4, HCMC, Quận 4
Thời gian làm việc
Thứ 2 - Thứ 6 (từ 08:30 đến 17:30)
- Hồ Chí Minh: 25th Floor E.Town Central, 11 Doan Van Bo, Dist 4, HCMC, Quận 4
Thời gian làm việc
Thứ 2 - Thứ 6 (từ 08:30 đến 17:30)
Thông tin chung
- Thu nhập: Thoả thuận
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