Senior Regulatory Affairs Specialist (Poland)

Indero (formerly Innovaderm) is looking for a Senior Regulatory Affairs Specialist to provide leadership for clinical trial regulatory activities and oversee global/multinational complex submissions.

Responsibilities

• Coordinate regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions; lead global/multinational submissions of complex large clinical trials.
• Address sponsor queries related to regulatory and submission requirements.
• Provide regulatory support and advice to project teams; offer project‑specific local submission strategy and technical expertise.
• Prepare/review core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance.
• Peer‑review documents and packages prepared by colleagues within the regulatory team.
• Develop and review Country ICFs.
• Perform regulatory review of essential documents and authorize regulatory release prior to shipment of investigational product to clinical sites.
• Develop and review country‑specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations.
• Participate in kick‑off meetings, client audits, and other project‑related meetings according to company or client needs.
• Act as a mentor to new or junior colleagues within the regulatory team (coaching, training, tool development, quality assurance).
• Support Regulatory Country Intelligence activities.

Requirements

• Bachelors degree (or equivalent) in a scientific discipline; Regulatory Affairs is an asset.
• 3–5 years in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry; experience preparing and submitting IRB/IEC packages and/or Clinical Trial Applications.
• Strong understanding of global regulatory requirements and guidelines in assigned countries/regions.
• Experience in a global leadership role with a focus on regulatory regions such as Europe and APAC (Australia/New Zealand); experience with the regulatory process under EU‑CTR.
• Fluency in English with excellent oral and written skills.
• Additional languages are an asset.
• Attention to detail and accuracy in work.
• Ability to organize own work, prioritize assignments, and work under pressure.
• Versatility and comfort in a multitasking environment.
• Respect for established timelines, expectations, priorities, and objectives.
• Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014.

Benefits

• Flexible work schedule
• Permanent full‑time position
• Comprehensive benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development

Our Company

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since 2000, we have built a solid reputation for the quality of our research and services. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. We will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Poland.

Seniority Level

Not Applicable

Employment Type

Full‑time

Job Function

Legal