Job Overview:

The Regulatory Affairs Manager will contribute to the development and the implementation of the regulatory strategy for the company. For this, he/she will be responsible for overseeing and managing all the activities related to regulatory and regulatory submissions and compliance subjects and will be the point of contact towards the Healthcare Authorities

Key Responsibilities:

Regulatory Affairs

• Life-cycle management of the registered medicinal products, cosmetics, medical devices and food supplements.
• Monitor and interpret regulatory developments, guidelines, and industry trends to provide strategic advice to the company.
• Preparation, reviewal, and submissions of regulatory documents to MOH for product approvals, renewals.
• Preparation and submissions of Marketing Authorization applications/line extensions in Vietnam.
• Submission at national level, Drug Administration of Vietnam (DAV) of variations/MA transfers notifications/ renewals for Mutual Recognition Procedure / Decentralized Procedure and national applications.
• Revision of artworks.
• Revision and approval of promotional materials according to local requirements and submission to the DAV.
• Annual price revisions.
• Management of relationships with HCP with Marketing, Sales and Medical Departments.

Pharmacovigilance– Local Safety Officer

• Ensure compliance with global policies and procedures and applicable local pharmacovigilance regulations.
• Ensure control and continuity of vigilance activities that are operated locally.
• Ensure implementation and maintenance of a local pharmacovigilance system in compliance with the Corporate Vigilance Guidelines and local regulation.
• Ensure PV training of personnel in the company.
• Ensure identification and management of safety data sources.
• Ensure processing and reporting of safety reports as well as periodic safety reports, risk management plans to the Global Vigilance Department and/or local Health Authority, in compliance with the Corporate Vigilance Guidelines and the local regulations
• Ensure immediate information to the Global Vigilance Department in case of safety issues, safety signals, Health authorities queries.
• Regarding the subcontracted activities, ensure that these ones are performed in accordance with global requirements/principles.

Quality Management System

• Ensure that the products are distributed in accordance with the GDP.
• Assessment of complaints, deviations and changes within the logistic process affecting all quality issues in customer care (e.g. product recalls, deviation in storage conditions) and logistics (e.g. batch release etc.)
• Ensure batch release process is established.
• Prepare and improve the general quality system management and its maintenance
• Prepare, participate and follow-up internal self-audits and audits of external business partners (warehouse)
• Generate and maintain reports of quality complaints
• Ensure compliance with local regulatory requirements and with the company policies and standard operating procedures (SOPs)
• Keep the local procedures updated according to the national legislation and according to the company SOPs

Key Requirements:

• Ensure all regulatory documents are meticulously reviewed and prepared with high accuracy and all submissions are complete and error -free.
• Able to analyze complex regulatory requirements and develop effective solutions.
• Interpersonal relationships
• Ability to interact with National Healthcare authorities
• Cross functional collaboration especially with Medical, sales and marketing departments
• Ability to adapt to changing regulatory environments and priorities.
• Developing innovative approaches to meet regulatory requirements.
• Anticipating regulatory challenges and addressing them proactively with pragmatism
• Managing multiple regulatory projects simultaneously with a high level of organization.
• Ensuring regulatory submission and responses are completed with deadlines.
• Strong knowledge/understanding of local regulations and willing to monitor and keep updated on a regular basis
• Qualifications
• Education: Bachelor’s degree in pharmacy, Medicine or related fields.
• Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of regulatory requirements and guidelines.
• Excellent communication, organizational, and project management skills. Ability to work independently and team player.
• Business communication and very good in English