Biocodex is a French family-owned pharmaceutical company headquartered in Gentilly, near Paris, France. The company was founded in 1953 to develop and market the world’s first probiotic yeast strain, Saccharomyces boulardii CNCM I-745®, discovered in 1923.
Building on relationships established for nearly 70 years with healthcare professionals, the Biocodex teams work daily for the health of all and focus their activities around three main areas:Microbiota, Orphan diseases, Women’s health.
With more than 1,800 employees, Biocodex generated net revenues of above €634 million in 2024, including 32% in France and 68% internationally. The group is present in more than 100 countries through wholly owned subsidiaries in 17 countries and a network of distributors worldwide.
In order to accompany the growth of Biocodex, we are looking for a: Regulatory Affairs Manager to contribute to the development and the implementation of the regulatory strategy for Biocodex Vietnam
The Regulatory Affairs Manager reports to General Manager of Biocodex Viet Nam and is one of the local Leadership team
YOUR RESPONSIBILITIES
Regulatory Affairs
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.
- Management of medical information/inquiries and provide the training and guidance to marketing team on regulatory requirements and best practices.
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 Biocodex Vietnam.
- 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 Biocodex Global policies and standard operating procedures (SOPs)
- Keep the local procedures updated according to the national legislation and according to Biocodex Global SOPs
QUALIFICATIONS
- 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
OTHER INFORMATION
Type of contract: Fulltime contract
Status:
Desired integration date: June/2025
Perks & Benefits:
Position open to people with disabilities
Type of contract: Fulltime contract
Status:
Desired integration date: June/2025
Perks & Benefits:
Position open to people with disabilities
WHY BIOCODEX
Our four values are driving forces and bonds for all teams: we play collectively; we shape fair relations; we dare to innovate; we care for our ecosystem.
Our four values are driving forces and bonds for all teams: we play collectively; we shape fair relations; we dare to innovate; we care for our ecosystem.
At Biocodex, we do not discriminate on the basis of gender, age, disability, nationality or sexual orientation. In fact, we welcome diversity, which we recognize as a source of strength for the company.
At Biocodex, our CSR approach is an holistic one to reconcile the « 4P’s »: « People, Planet, Profit and Purpose » and we also ensure that our employees are provided with necessary and relevant tools for both their personal and professional development, while offering them competitive advantages and services.
Join us!
Biocodex Vietnam
Take up the challenge and send your application!