For our client, an international company in the pharmaceutical sector, we are looking for a Regulatory Affairs Specialist to support market compliance activities, post-marketing safety processes, and quality operations for assigned markets. The role is based in Bucharest and is suited to a professional who can work cross-functionally, manage sensitive documentation, and ensure compliance with local and EU requirements.

Main responsibilities

• 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.

Candidate profile

• 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.

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.

Attention:

• The recruitment process will be conducted through QPAS.
• Only eligible candidates will be contacted.
• By applying to this job, we are deemed to have your default consent to the processing of personal data by QPAS, pursuant to Regulation (EU) 2016/679.