Adecco's Client - a global leader in pharmaceuticals and diagnostics - is looking for a Regulatory Affairs Executive(Contract 8 months - Open for Fresh) with the below information:
Contract: 8 months
Salary:12,000,000 - 13,000,000 VND Gross
Location: Pearl Plaza - Dien Bien Phu, Binh Thanh District, HCMC
Work hours: Mon - Fri | 9:00 AM - 6:00 PM
Job purposes/Job summary:
Regulatory Affairs Executive is in charge of obtaining and maintaining government approval for IVD
medical devices. They often advise stakeholders on subjects such as premarket regulatory requirements, labeling requirements, or policy compliance matters
Responsibilities:
- Plan, manage & execute registration according to regulatory requirements and relevant government regulations for new launched in-vitro diagnostic products.
- Plan, manage & execute new registration projects as assigned by RA manager.
- Follow products change notification update and submit change/ amendment dossier for approved products.
- Declaration on MoH portal for products promotional material/symposium for marketing activities.
- Ensure the products classification are compliant with regulatory requirements and relevant government regulations as well as global recommendation.
- Ensure products license are compliant with regulatory requirements with the necessary supporting document.
- Review and approve for the local sub-label, re-dressing instruction, maintain the compliance with local regulation and global recommendation.
- Manage the translation of all products package inserts for uploading to e-library and for local distribution where compliance with local regulation, global recommendation and request from business.
- Store, organize and maintain the Regulatory certificates, registration product dossier and RA documentation in accordance with organization's policy.
- Collaborate and/or provide consultancy for key stakeholders to ensure the business development and continuity while ensuring the compliance.
- Collaborate with government team and industry on providing opinion for draft regulations, as well as analyzing the impacts by new regulation and built action plans if any.
- Organization of certificates (free sales cert and etc.) and registration product dossier.
- Other duties may be assigned by the management
Liaises With:
- Global RA to manage product and application related matters, technical support, updates and enquiries.
- Regulatory affairs department of Roche affiliates
- Relevant Internal Team members including Sales, Marketing, Finance, Logistics, Service,
- Application and other departments/areas as required
- Internal logistics team for product registration and importation related matters
- Vietnam Ministry of Health (DMEC)
- Customs
- Notarization offices
- Suppliers: DKSH, Translation agencies, ...
- External consultant
- Industry Association (Eurocharm,... )
Requirements:
- Bachelor Degree in Health/ Science/ Medical Technology disciplines
- Open for Fresh or candidates from 6 months of experience in regulatory affairs and at MNCs environments is preferred (internship experience is welcomed)
- English: good reading, writing & listening, fluent communication is a plus
- Personal Computer Skills (Microsoft Office Application)
- Effective Communication Skill
- Good Interpersonal Skill
- Creative Problem-solving Skill
- Time Management Skill
- Ability to work independently and as team player
- Self-initiative and Proactive
Career development for this position:
- This position will give you the opportunities to learn and the business and the cutting-edge practices of leading MNC company with experiences to apply them for local business development.
- Roche can provide the wide variety of career development opportunities both domestically and internationally.
Contact:
- Email: [Confidential Information]
- Phone: 0901444313
