Head of Regulatory Affairs

Job Summary:

The Head of Regulatory Affairs will lead and oversee all regulatory strategies and activities to ensure the company's pharmaceutical products comply with applicable laws and regulations in domestic and international markets. This leadership role involves managing submissions, approvals, and maintaining relationships with regulatory authorities to facilitate smooth product registrations and market access.

Key Responsibilities:

·        Regulatory:

-       Manage regulatory requirements, including registration, obtaining and maintaining MA in Vietnam and regional country in SEA, etc...

-       Provides clear, constructive regulatory advice and guidance to the organization.

-       Direct the preparation, submission dossiers (initial, re-registration, extension, variations, GMP assessments, etc..) and supplement the required dossiers to Regulatory Authorities.

-       Monitoring the registration process: guiding and supporting staff in the process of preparing and submitting drug registration documents; ensure compliance with technical and legal requirements. Review all documents submitted to the regulatory authorities to ensure timeliness, accuracy, comp leteness, and compliance with legal standards.

-       Review Agreements, MOUs, service contract, etc.

-       Update, check and approve labels (artworks, including cartons, foils, package insert, sub-label, etc...) before taking production; confirm actual photo (box and blister) and CoAs before supplying the goods to destination countries.

-       Monitor the lookup/update of information on Pharmacy/Health Supplement, Medical Devices regulations, Cosmetics as well as information on registration operations;

-       Responsible for and organizing the implementation of tasks related to product registration (Drugs, Health Supplement, Cosmetics, Medical Devices, etc...)

-       Update regulations in the pharmaceutical industry in general and product registration in particular (legal documents, procedures, circular, decisions, etc... related to drug registration, price declaration, bidding, quality management, etc.)

● General:

-       Strategic planning in the short and long-term for the business in current and future markets from a technical Regulatory perspective.

-       Analyze, survey, and evaluate and select products before signing agreement with manufacturer

-       Building up the closely and good relationship Regulatory Authorities and organizations related.

-       Co-ordinate with BD team, importers and manufacturers to ensure products quality after circulating in the market.

-       Attend local and regional conferences/workshop/meetings concerning regulatory

-       Works with C.R/Director to allocate sufficient resources to complete plans in a timely manner.

-       Budget oversight with managers on general expenditure.

-       Fosters accountability within the team to meet established timelines.

-       Providing guidance and coaching to departments with problem solving related to importing products and skills development to aid learning and early problem resolution

-       Planning regulatory requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry

-       Planning a business trip to Hanoi and Overseas.

-       Responsible for day-to-day compliant management activities with C.R/Director and resolution of all quality and regulatory affairs related issues

-       Leading meetings with parties and representing the business on quality and regulatory affairs aspects in a professional manner

-       Attendance at weekly/monthly management meetings, Regulatory Meetings, etc.

-       Overseeing and being responsible for ensuring that Regulatory is implemented and executed within budget and timelines.

-       Monitoring and introduction of additional quality and regulatory metrics and reports to C.R/Director.

-       Prepare an annual Regulatory Affairs Budget and ensuring the Resources are been utilised efficiently and effectively.

-       Present to company from time to time on Regulatory Affairs related activities

● Personnel Management:

-       Recruiting and managing the RA team members.

-       Train staff in regulatory policies or procedures.

-       Develop and update SOPs, training manual and guidance RA team members to improve work efficiency

-       This includes, but is not limited to, setting team and individual objectives, carrying out performance appraisals, generating training plans and dealing with performance related issues.

● Perform other assigned related tasks

Qualifications:

·        Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or related field.

·        Minimum 8-10 years experience in pharmaceutical regulatory affairs, including at least 3 years in a managerial or leadership role.

·        Deep knowledge of regulatory requirements and submission processes in key markets (e.g., Vietnam, ASEAN, US, EU).

·        Experience with electronic submission systems (eCTD) and regulatory databases.

·        Strong leadership, communication, and negotiation skills.

·        Ability to work under pressure and manage multiple projects simultaneously.

Key Skills:

• Regulatory strategy development
• Product registration & dossier management
• Knowledge of international regulatory frameworks (FDA, EMA, WHO, ICH)
• Team leadership and project management
• Risk assessment & mitigation
• Strong interpersonal and stakeholder management skills

Preferred:

•       Experience in pharmaceutical product lifecycle management

•       Familiarity with GMP, GDP, and other quality standards

•       Ability to work independently and as part of a team

•       Proficiency in English (written and spoken)