Title : Sr. Regulatory Affairs Specialist

Location : Poland

Experience : 6+ years in Medicinal Products Regulatory Affairs

Freyr Solutions is a fast‑growing, innovative company specializing in end‑to‑end regulatory solutions for the Life Sciences industry. We assist pharmaceutical, medical device, and biotech companies in navigating regulatory compliance.

We’re looking for a passionate and skilled Regulatory professional to join us in shaping the future of regulatory services.

Job Description

• Understand the regulatory framework, including regional trends, for various types of post‑approval change applications and procedures across EU and other European markets.
• Evaluate the change control and provide regulatory assessment on procedural and documentation requirements as defined by health authorities for assigned deliverables in coordination with client team.
• Good understanding of EU Regulatory framework (National, MRP/DCP and CP).
• Prior experience in handling biological/vaccine products preferred.
• Author applicable Module 1 documents for different types of submissions (variations, renewals, HA query responses, Art 46, PSURs, PASS, PAM).
• Review submission documents and provide regulatory input (e.g., Variation, renewal, response documents, high level documents, regulatory maintenance documents/aggregate safety report/PSUR, etc.).
• Use and share best practices, regulatory updates and lessons learned, when handling various applications in day‑to‑day work.
• Contribute to planning, preparation, and delivery of both simple and complex regulatory maintenance submissions.
• Liaise closely with cross‑function team members with aligned product responsibilities.
• Execute and maintain submission deliver plans, submissions content plan and proactively provide status updates to designated stakeholders.
• Identify regulatory risks and communicate mitigation to cross‑functional team.
• Contribute to various safety reports and addendum statements for submissions in assigned region worldwide.
• Coordinate, plan, and prepare post‑marketing or post‑approval changes applications (variation/renewal/MAH transfer/other submissions activity/EDQM coordination as applicable) and respond to queries received from health authorities.
• Prepare applicable Module 1 documents for submissions and briefing documents for scientific advice.
• Coordinate with client EU Regulatory leads and local affiliates for inputs on strategies and timelines of all submissions.
• Coordinate with Client Global and Regional counterparts to ensure successful regulatory submissions.
• Perform QC of published sequences for regulatory adequacy and eCTD aspects.
• Provide necessary regulatory inputs for safety reports, renewals, and other deliverables (Art 46, PAM/PASS, PIP, Annual reports-reassessment).
• Contribute and support regulatory operational activities.
• Develop and maintain effective working relationships with Global Regulatory Teams, cross‑functional teams, consultants and business partners as required.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Other

Industry

Pharmaceutical Manufacturing