Job Title: Senior European Regulatory Affairs Manager – Pharmaceutical Formulations & Dossier Management
Location: Europe (Czech Republic / United Kingdom)
Experience Required: Minimum 5 years in Regulatory Affairs
Company: Vizen Life Sciences Pvt Ltd
Employment Type: Full-Time
Vizen Life Sciences Pvt Ltd is a leading global pharmaceutical consultancy with a strong presence in Europe, including affiliates in the Czech Republic and the United Kingdom. We specialize in providing strategic regulatory guidance, dossier preparation, and lifecycle management for pharmaceutical products. Our team is committed to delivering high-quality, compliant solutions to clients across Europe and beyond.
We are seeking a Senior European Regulatory Affairs Manager with extensive experience in pharmaceutical formulations and dossier preparation. In this role, you will lead regulatory affairs activities for assigned registration projects, ensuring smooth dossier compilation, submission, and management across multiple European jurisdictions. You will collaborate directly with EU affiliates, junior RA team members, and EU regulatory authorities to maintain compliance and streamline registration processes.
This is an ideal opportunity for a regulatory affairs professional aiming to make a strategic impact within a dynamic global consultancy.
End-to-End Registration Management: Oversee registration projects across the entire product lifecycle, including new registrations (CP, DCP, MRP, national procedures), renewals, variations, withdrawals, and sunset clauses.
Dossier Compilation & Submission: Prepare, review, and manage regulatory dossiers in CTD, eCTD, NTA, ACTD, or other formats, focusing on Modules I, II, IV, and V in collaboration with manufacturers.
Regulatory Compliance: Ensure adherence to registration timelines and legislative requirements within assigned projects.
Stakeholder Collaboration: Work closely with EU affiliates, internal teams, and external partners, including EU regulatory authorities, to facilitate approvals and maintain compliance.
Process & Training Oversight: Support change control management, risk assessment, and reporting while providing guidance and training on regulatory software and systems.
Team Leadership: Provide line management and mentorship to junior RA team members.
Degree in Pharmacy, Medicine, or Life Sciences.
Minimum 5 years of experience in regulatory affairs within the pharmaceutical industry.
Advanced knowledge of marketing authorization processes and CTD dossier preparation.
Proven experience in dossier compilation and regulatory submissions for medicinal products.
Strong organizational, analytical, and communication skills.
Fluency in English; additional European languages are a plus.
Flexibility, reliability, and enthusiasm for learning new regulatory frameworks and tools.
Advanced degree (Master’s, PhD) in a relevant field.
Regulatory Affairs Certification (RAC).
Experience with electronic regulatory submission systems.
Prior experience in a similar senior RA role, especially in dossier preparation and marketing authorization maintenance.
Lead strategic regulatory affairs initiatives across Europe.
Collaborate with industry experts, EU affiliates, and top professionals.
Gain exposure to diverse pharmaceutical formulations and regulatory submissions.
Thrive in a dynamic, supportive, and globally connected work environment.
Apply Now to take the next step in your regulatory affairs career as a Senior European Regulatory Affairs Manager and make a significant impact in the pharmaceutical industry.
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