德国制药公司,具有OTC非处方药和保健品(健字头注册)注册经验
Field/s of Responsibility
Regulatory support for new Product Development projects
1. Provide technical support during formulation design, to ensure regulatory compliance (eg. Ingredients, dosage, etc).
2. Provide technical support during package design/approval, to ensure regulatory compliance.
3. Provide technical support during dossier preparation.
4. Provide regulatory support/interpretation to contract manufacturer.
5. Act as technical interface with regulatory authorities(such as CDC, etc)
6. Supervise service quality of regulatory consultants
Regulatory support for existing products
1. Provide regulatory support in brand maintenance (Basic rules compliance in POSM development, regulatory related customer/consumer response, etc)
2. To support supplier qualification process
Provide internal regulatory training
1. Provide regulatory training to project team on technical area.
2. Provide regulatory training to sales/marketing team if requested.
Maintain of NBD database
1. Maintain in good quality of Merck NBD database
Required Competencies
Good understanding on regulatory requirement on health food/food industry.
Strong interpersonal communication skills;
Strong problem solving ability
Creativity
Self-learning
Personal requirements ( include experience, knowledge，skills and education)
1. BS degree or above in pharma, food, chemistry or related field.
2. Minimum 3 years working experience in regulatory area in pharmaceutical/health food/food industry. Experience in health food industry is preferred. Experience with multinational company is preferred.
3. Strong understanding on regulatory requirement for Health food/food industry is required.
4. Experience in QC and production is preferred but not a must.
5. Understanding of GMP guideline is preferred.
6. Fluent in English (verbal & written)
