This is a remote position.
About Arriello:
At Arriello, we provide a full range of Pharmacovigilance, Quality & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies. With a team of experienced professionals, we support our clients in meeting their regulatory obligations, maintaining product quality and patient safety, and navigating complex global compliance landscapes.
As a growing business with a dynamic culture, we are committed to high-quality delivery, continuous improvement, and creating an environment where people can thrive.
At Arriello, our values define how we work — and who we are:
Inclusive - We value equity, inclusion and dignity for all, recognising that we learn from each other every day.
Dedicated - We challenge the status quo to deliver pragmatic, tailored solutions for our clients.
Innovative - We collaborate closely—with our clients, colleagues and partners—to proactively find better ways forward.
Passionate - We build strong relationships based on empathy, respect and a genuine commitment to delivering quality in everything we do.
The opportunity
We are seeking an experienced Regulatory Affairs Specialist/Manager to take full ownership of local regulatory activities in Czechia. This is a broad and autonomous position where you will act as the key local point of contact for health authorities, partners, and clients.
You will be responsible for managing the full lifecycle of regulatory operations, from strategy and submissions through to approvals, translations, and maintenance activities. Experience in Pharmacovigilance is considered an advantage but is not required.
This role is suited to someone who is confident working independently, comfortable managing complexity, and motivated to deliver high‑quality outcomes in a dynamic environment.
What you will do
Regulatory AffairsRegulatory Affairs
- Act as the local Regulatory point of contact for Czechia, providing support to regulatory strategy and submission planning.
- Provide local expertise for submissions, including pre‑submission activities and interactions with health authorities.
- Prepare and support submission dossiers, including application forms, cover letters, and supporting documentation.
- Manage submission processes, including portal submissions, agency-specific requirements, and regulatory fee coordination.
- Manage validation queries and responses to Requests for Further Information, ensuring timely and accurate communication.
- Handle regulatory approvals and act as the primary contact for queries and correspondence with health authorities.
- Ensure accurate documentation, data management, and archiving in relevant systems (for example, Veeva).
- Provide scientific Czech translations of SmPC, PIL, packaging, and labelling, including proofreading and quality checks.
- Monitor local Czech regulatory developments and communicate impacts on assigned products.
- Support Braille verification and certification procedures through local authorities.
- Provide broader regulatory and quality support, including shortages notifications, repacking approvals, GS1 activities, local compliance steps, and FMD or NMVO‑related responsibilities.
End‑to‑End Regulatory Support for the Czech Market
Including but not limited to:
- Regulatory strategy, planning, and local input.
- Pre‑submission engagement with authorities and advising on local requirements.
- Preparation of dossiers and final‑mile submissions.
- Handling of local portal submissions, documentation requirements, and fee payments.
- Managing RFIs, RTQs, and submitting prepared responses.
- Managing approvals, correspondence, and issue resolution.
- Maintaining accurate records and archiving documentation.
- Providing high‑quality Czech translations for all product information.
- Monitoring regulatory changes and identifying product impacts.
- Managing local Braille text confirmation and certification.
- Supporting quality and business activities (shortages, GS1, repacking, safety/quality queries, NMVO engagement).
Requirements
Education
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related scientific field.
Experience
- Proven experience in Regulatory Affairs within the pharmaceutical industry, preferably involving prescription medicines and vaccines.
- Strong experience managing the full regulatory lifecycle in Czechia, including national procedures, variations, renewals, and maintenance.
- Hands‑on experience interacting with the Czech State Institute for Drug Control (SÚKL) is preferred.
- Solid understanding of EU pharmaceutical legislation and Czech local regulatory requirements.
- Pharmacovigilance experience is an advantage.
- Demonstrated experience in field‑based or hands‑on regulatory work.
- Proven ability to interact effectively with external partners, clients, and health authorities.
- Strong organisational and project management skills.
- Ability to work independently and take ownership of responsibilities.
Preferred
- Experience working with human medicines across prescription, over‑the‑counter, and vaccine portfolios.
- Slovak language would be an advantage.
Language Requirements
- Czech — fluent / professional level (mandatory)
- English — professional working proficiency
- Slovak — nice to have
Benefits
- Work remotely while contributing to a global life sciences consultancy .
- Lead quality operations that directly influence patient safety and regulatory compliance.
- Collaborate in a multicultural, inclusive, and innovative environment.
- Enjoy opportunities for career progression, professional development, and international exposure.
- Flexible Work Options : Remote working flexibility to support your lifestyle.
- Generous Time Off: Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
- Home Office Support: Get support to create a productive home office setup.
- Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.
Arriello is an Equal Opportunity Employer. We are committed to creating a diverse, inclusive, and respectful workplace where all individuals are valued and treated with dignity. We encourage applicants from all backgrounds, including but not limited to race, colour, religion, gender, gender identity, sexual orientation, age, disability, national origin, or any other characteristic protected by law.
In line with our commitment, we provide reasonable accommodations to applicants with disabilities throughout the hiring process. If you require any accommodation, please contact us at recruitment@arriello.com .
