Senior Regulatory Affairs Specialist Romania

The Senior Regulatory Affairs Specialist will lead regulatory activities for clinical trials, oversee complex submissions, and support global/regional regulatory strategies within a pharmaceutical/biotech/CRO environment.

Location: Romania

Responsibilities

• Coordinate regulatory timelines and lead global/multinational submissions for complex large clinical trials.
• Address sponsor queries related to regulatory and submission requirements.
• Provide regulatory support and advice to project teams; develop local submission strategies.
• Prepare and review core and country-specific submission packages to ensure compliance.
• Peer review of regulatory documents and packages.
• Develop and review country-specific informed consent forms (ICFs).
• Perform regulatory review of essential documents and authorize regulatory release for investigational products.
• Develop and review country-specific labelling content for clinical trial drugs.
• Participate in project meetings, audits, and client interactions.
• Mentor junior regulatory team members and support regulatory country intelligence activities.

Requirements

• Bachelor's degree in a scientific discipline, Regulatory Affairs experience is an asset.
• 3-5 years in clinical regulatory affairs within pharmaceutical, biotech, or CRO industry.
• Experience preparing and submitting IRB/IEC packages and Clinical Trial Applications.
• Strong understanding of global regulatory requirements, especially in Europe and APAC.
• Experience with EU-CTR and global leadership roles.
• Fluency in English; additional languages are a plus.
• Attention to detail, organizational skills, ability to work under pressure.
• Knowledge of good clinical practices, Health Canada, FDA, and EU Regulation No 536/2014.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Complete benefits package including medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, transportation rebates, social activities.
• Ongoing learning and development opportunities.

Additional Information

• The company is Indero, a CRO specializing in dermatology and rheumatology, based in Montreal, expanding in North America and Europe.
• The role is based in Romania and requires legal eligibility to work there.
• The company values integrity, commitment, and teamwork.