Ideal Candidate
- Bachelor’s degree in Pharmacy, Medicine or a related field.
- Minimum 2 years of experience in Regulatory Affairs, Pharmacovigilance, Quality Assurance, or a similar compliance-focused role.
- Good understanding of pharmaceutical regulations, post-marketing safety processes, and quality standards.
- Fluent English and Romanian, both written and spoken.
- Strong attention to detail, solid planning skills, and the ability to manage multiple priorities and deadlines.
- Professional communication style and the ability to work effectively with both local and international stakeholders.
- Experience with regulated documentation systems or compliance platforms represents an advantage.
Job Description
- Manage regulatory activities related to product registrations, variations, renewals, and maintenance of marketing authorization documentation for assigned markets.
- Monitor local regulatory and pharmacovigilance requirements and support implementation of new legal or procedural changes to maintain compliance.
- Handle post-marketing safety activities, including adverse event follow-up, technical complaint coordination, case documentation, reconciliation, and submission to health authorities where required.
- Maintain and update local SOPs, quality records, archives, and compliance documentation in line with internal procedures and external regulations.
- Support quality assurance activities across distribution, storage, transport deviations, vendor documentation, recalls, and quality agreements.
- Act as a key contact for internal stakeholders, external partners, distributors, and service providers on regulatory, safety, and quality-related topics.
- Contribute to inspections, audits, training activities, deviation handling, and continuous improvement initiatives.
What Our Client Offers
- Opportunity to join a stable international environment in a highly regulated industry.
- Exposure to regional regulatory, safety, and quality processes.
- A role with strong visibility and interaction across multiple business functions.
- Professional development in a complex compliance-driven position.
Company Description
About QPAS
One person (vision)
For us, small means bigger motivation. And passion. And working person-to-person.
Nothing is impossible. Every person has its place. Our role is to bring them together, with dedication and responsibility. Through expertise and concrete tools, we make sure that we�ll find the right one for you. And we are doing so by personally knowing the candidates and the companies, evaluating them thoroughly and then searching what fits them best.
One goal (mission)
When you work with people and for people you should consider their best interest and act accordingly. In human resources area, their success is our success.
One person (vision)
For us, small means bigger motivation. And passion. And working person-to-person.
Nothing is impossible. Every person has its place. Our role is to bring them together, with dedication and responsibility. Through expertise and concrete tools, we make sure that we�ll find the right one for you. And we are doing so by personally knowing the candidates and the companies, evaluating them thoroughly and then searching what fits them best.
One goal (mission)
When you work with people and for people you should consider their best interest and act accordingly. In human resources area, their success is our success.
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