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 Croatia. 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 to approvals and maintenance activities. Pharmacovigilance experience is considered an advantage. This role is ideal for someone who is confident working independently, comfortable managing complex requirements, and motivated to deliver high‑quality outcomes in a dynamic environment.
What you will do
Regulatory Affairs
- Act as the local Regulatory point of contact for Croatia, supporting regulatory strategy and submission planning.
- Provide local expertise and input into submissions, including pre‑submission activities and engagement with health authorities.
- Prepare and support submission dossiers, including application forms, cover letters, and supporting documentation.
- Manage submission processes, including local portal submissions, agency requirements, and coordination of regulatory fees.
- Handle validation queries and manage responses to Requests for Further Information, ensuring timely and accurate communication.
- Manage regulatory approvals and act as the primary contact for regulatory queries and correspondence.
- Ensure accurate documentation, data management, and archiving in relevant systems (for example, Veeva).
- Deliver high‑quality scientific translations of product information, including SmPC, PIL, and packaging components.
- Monitor Croatian regulatory developments and assess impacts on products.
- Support Braille verification and certification activities with local authorities.
- Provide broader regulatory and quality support, including shortages notifications, repackaging approvals, GS1 support, and FMD‑related responsibilities.
End-to-End Regulatory Support for the Croatian Market
Responsibilities include:
- Regulatory strategy and submission planning.
- Local input for submissions and pre‑submission engagement with authorities.
- Preparation of submission dossiers and final‑mile submission activities.
- Coordination of agency‑specific requirements (including portal submissions and payment of local regulatory fees).
- Management of validation queries, RFIs, and submission of prepared responses.
- Management of approvals, queries, and official correspondence.
- Data management and document archiving (for example, Veeva).
- Scientific Croatian translations for SmPC, PIL, labels, and proofreading.
- Monitoring and reporting on local regulatory changes.
- Braille verification, translation confirmation, and certification processes.
- Local representative duties such as shortages notifications, quality and safety queries, repacking support, GS1 activities, and 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 working with prescription medicines and vaccines.
- Strong experience managing the full regulatory lifecycle in Croatia, including national procedures, variations, renewals, and maintenance activities.
- Solid understanding of European pharmaceutical legislation and local Croatian regulatory requirements.
- Experience in Pharmacovigilance is an advantage.
- Demonstrated experience in field‑based or hands‑on regulatory work.
- Proven track record of direct interaction with local health authorities and external partners or clients.
- Ability to work independently and take ownership of responsibilities.
- Strong organisational and project management skills.
Preferred
- Experience with human medicines across prescription, over‑the‑counter, and vaccine portfolios.
Language Requirements
- Croatian — fluent / professional level (mandatory)
- English — professional working proficiency
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 .
