Job summary: The role will support Regulatory Affairs Manager for with respect to strategy development and execution in regulatory affairs to provide strategic directions to the business, embed functional capabilities to enable growth, and is accountable for delivering project goals and aligning functional strategies with business needs.

Key Responsibilities:

• Ensure compliance with, and maintenance of, existing licenses, effective and timely approval of all marketing authorizations for drugs, cosmetic and medical device, appropriate input on the development of new products, renewal and variation product registration and shaping of the regulatory environment in markets in scope.
• Timely preparation, submission and obtain (re) registration and variation as plan. 
• Ensuring/maintaining regulation affairs governance in accordance with company standards and promote innovation opportunities across portfolio, contributing to develop local product strategic registration plans. Provide regulatory & medical information support for marketing activities. 
• Ensuring regulatory advice and input is proactively provided to local business strategies with regards to feasibility, requirements and timelines, taking into account local requirements and local business needs. 
• Ensure high quality and timely submissions. Prepare and submit regulatory affairs applications such as new product registrations (including geographical extensions and variations (e.g. extension of indication) across regulatory product classes (prescription drugs, OTC drugs, cosmetics and medical devices) to respective Health Authorities to meet country’s business objectives and timelines. 
• Perform regulatory maintenance of registered products or ingredients (including review of product inserts, sublabel; submissions of variations and permits) to ensure products remain compliant with all relevant government, industry and company requirements throughout their marketed life. To this end, ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses, as well as ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to company requirements. 
• Review promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Ensures consistency and conformity to the various published guidelines.
• Review proposed product labels and formula for regulatory assessment and submit to register label and formula changes to the relevant health authority with the aim of attaining the most competitive product labels (whilst maintaining ethical standards) and the earliest possible commercial launch.
• Manage in-house regulatory files, documentation and databases ensuring that all files are up-to-date and compliant. 
• Provide regulatory, technical and scientific information to Business Units and other functional support departments where required. 
• Review all packaging artworks and promotional literature from a regulatory & medical affairs perspective as per internal and company SOPs in place. 
• Answer and follow-up medical information and product-related queries Quality Assurance and other product complaint. 
• Implementation, oversight and management of a local vigilance system and its activities in order to contribute to the pre/post marketing surveillance and the safe use of Company products (drugs, cosmetics and medical devices) according to local regulatory requirements, company quality and pharmacovigilance standard.

OTHERS

• Foster and maintain good cross-functional working relationships with other departments
• Liaise with company for local Trademarks and other related local legal issues

Key Requirements:
1. Education/Training:
- Degree in Pharmacy,  Pharmaceutical Sciences is prefered. 
- Knowledge of products and related disease states is required to interpret information
- Licensed Pharmacist in Vietnam 
2. Work Experience: 
- 3 years regulatory experience at regulatory executive/speicalist level preferably with experience in QA and/or PV and/or Medical Information, 
- Familiar with Vietnam cosmetics, prescription, OTC and medical devices registration procedures and regulatory aspects. 
3. Required pre-requisites skills/experience:
- Good understanding of the consumer healthcare and pharmaceutical industry, drug development environment, and R&D processes and objectives;
- Expert knowledge of medicinal product, cosmetics and medical devices regulations, requirements and applicable laws for Vietnam;
- English fluency;
- A good understanding of the commercial drivers of the Pharmaceutical industry and an associated ability to provide advice/guidance that takes these into consideration;
- Good, positive and proactive communication and the ability to foster excellent working relations with external customers including the Health Authorities, Industry Associations and internal stakeholders; 
- Be able to balance company commercial needs with compliance requirements;
- Strong team player, assisting others with workload peaks and the management of challenging situations;
- Proactively contributes to a positive team attitude and highly productive work environment