RV Group is a Multinational pharmaceutical company with a significant presence in the ASEAN and CIS regions. We have more than 3500 employees across 9 countries spanning India, Vietnam, Kazakhstan, Philippines, Cambodia, Uzbekistan, Thailand , Vietnam, Middle East and Africa. At RV Group, we always strive to improve the Quality of life for our patients by providing high quality and affordable products for both curative and preventive purpose.
Website: https://rvgroups.co/
Address: 94-96, Nguyen Van Kinh Street, Cat Lai Ward, Ho Chi Minh City
Workplace: 94-96 Nguyen Van Kinh Street, Cat Lai Ward, Ho Chi Minh City
Working time: Mon – Friday (8am – 5pm/9am – 6pm) & Sat morning (8am – 12pm)
Position: Senior Regulatory Affairs Executive
Main Responsibilities
Strategic Dossier Management:
- Dossier Leadership & Strategy: Independently formulate registration strategies, compile, and finalize complex regulatory dossiers for submission to the Ministry of Health (MOH); proactively advise and propose strategic solutions to the RA Manager/Director.
- Import Dossier Management: Lead the collection, rigorous review, and alignment of foreign product documentation; directly engage and negotiate with regulatory authorities during the review process to resolve complex regulatory bottlenecks.
- Toll Dossier Coordination: Act as the primary liaison between internal stakeholders, contract manufacturers, and authorities to prepare toll manufacturing dossiers—ensuring regulatory feasibility, data integrity, and strict compliance.
Ownership & Leadership:
- End-to-End Dossier Ownership: Take full strategic and operational accountability for the entire dossier lifecycle—from initial risk assessment, critical review, and submission to proactive follow-up and resolution for all dossier categories (New Registrations, Renewals, Major/Minor Variations, GMP certifications, etc.).
- Submission Roadmap & Scheduling: Develop, maintain, and optimize proactive submission roadmaps; anticipate potential delay risks and establish contingency plans to ensure on-time product launch and market access.
- Regulatory Compliance & Oversight: Maintain robust compliance oversight for all approved products within scope; continuously monitor, evaluate impact, and implement newly issued MOH regulations into business operations.
Expertise & Capability Elevation:
- Regulatory Advisory & Subject Matter Expertise: Deeply analyze current and upcoming laws, decrees, circulars, and draft regulations; serve as an internal regulatory subject matter expert advising Commercial, Supply Chain, and Marketing teams.
- Strategic Response Drafting & Advocacy: Lead the drafting of high-stakes, technically sound, and persuasive response/explanation letters to regulatory bodies to facilitate smooth evaluations and accelerate approval timelines.
- Mentorship & Coaching: Provide technical guidance, review support, and mentorship to Junior RA Executives/Specialists to elevate overall team capability and technical accuracy.
Requirements:
- Bachelor's degree in Pharmacy
- At least 2 years of experience in RA (imported products)
- Detail-oriented, careful with documentation, and eager to learn regulatory procedures.
- Good teamwork, communication, and time management skills.
- Good English reading and writing skills, especially for technical and regulatory documents.
Benefits:
- Competitive salary, negotiable based on qualifications and experience
- Health insurance coverage and full statutory benefits provided in accordance with labor law
- Lunch provided at the office and full working equipment provided (laptop/PC)
- Opportunities for continuous learning, professional development, and a clear career growth path
- Friendly working environment with team-building activities, along with gifts for holidays, Tet, and birthdays
