You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self‑care works for millions of people and need leaders and experts ready to shape what’s next. As a Regulatory Specialist, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

Job Purpose

The Site Regulatory Specialist supports regulatory compliance and product registration activities for products manufactured at the site and supplied to Vietnam and 11 export markets. The role prepares and maintains regulatory dossiers, evaluates alignment between registered dossiers and actual site practices, verifies product labeling, and coordinates regulatory data and documentation with internal and external stakeholders.

Key Accountabilities

Prepare and compile registration dossiers for pharmaceuticals, health supplements, and cosmetic products, including new product registrations, renewals/extensions, and post‑approval variations for Vietnam and 11 export markets.
Conduct gap assessments between approved registration dossiers and actual manufacturing and quality control practices, including alignment with applicable site procedures.
Develop and propose action plans to address identified regulatory gaps, in collaboration with the Department Head, to ensure ongoing product regulatory compliance.
Review and verify product labeling content to ensure consistency with approved registration dossiers and approved labeling information.
Provide approved product specifications to quality control institutes and relevant authorities upon request.
Coordinate the registration and maintenance of product barcodes.
Prepare and coordinate import license applications for raw materials, packaging materials, and reference standards.
Maintain and update regulatory data in Opella global systems as required.
Provide regulatory documentation and support for internal and external audits, as applicable.
Perform delegated regulatory activities during the absence of the Site Regulatory Lead, in accordance with appropriate instructions and authorization.
Participate in and support Health, Safety and Environment (HSE) activities as required.

Candidate Profile

Education

Bachelor's degree in Pharmacy, Chemical Engineering, Biological Engineering or a related discipline.
Professional proficiency in spoken and written English, particularly in quality and regulatory contexts.

Experience and Knowledge

Two to three years of experience in CMC dossier preparation and pharmaceutical, health supplement, cosmetic product registration.
Knowledge of product registration, Good Manufacturing Practice (GMP) and applicable regulatory requirements.

Core Competencies

Strong analytical and problem‑solving skills.
High attention to detail and accuracy in regulatory documentation.
Effective communication and cross‑functional collaboration skills.
Ability to organize priorities and manage multiple regulatory deliverables.

This is more than the next step in your career, it’s a chance to lead change and help reinvent self‑care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.

About Us:

Opella is the self‑care challenger with the purest and third‑largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.

Our mission is to bring health in people’s hands by making self‑care as simple as it should be. For half a billion consumers worldwide – and counting.

At the core of this mission is our 100 loved brands, our 11,000‑strong global team, our 13 best‑in‑class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at

Site Regulatory Specialist

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