Senior European Regulatory Affairs Manager – Pharmaceutical Formulations
Company: Vizen Life Sciences Pvt. Ltd
Location: Europe (Czech Republic / United Kingdom)
Employment Type: Full-Time
Experience Required: 5+ Years in Regulatory Affairs
Educational Qualification: Degree in Pharmacy, Medicine, or Life Sciences; Master’s/PhD preferred
Certification: Regulatory Affairs Certification (RAC) preferred
Job Overview
Vizen Life Sciences, a leading global pharmaceutical consultancy with European affiliates in the Czech Republic and the United Kingdom, is seeking an experienced Senior European Regulatory Affairs Manager.
The successful candidate will lead dossier management and regulatory submissions for pharmaceutical formulations, coordinate with EU affiliates and authorities, and guide junior regulatory affairs team members. This role offers the opportunity to be at the forefront of regulatory strategy, ensuring compliance and timely approvals across product life cycles.
Key Responsibilities
1. Regulatory Project Management
Lead registration projects throughout the product life cycle, including:
New registrations via CP, DCP, MRP, or national procedures
Renewals, variations, withdrawals, and sunset clauses
Ensure all registration procedures follow the established registration plan.
2. Dossier Compilation & Management
Compile registration dossiers, focusing on Modules I, II, IV, and V (manufacturing modules in collaboration with manufacturers).
Prepare dossiers in CTD, eCTD, NTA, ACTD, or other formats compliant with current European legislation.
Maintain dossier quality and ensure compliance with regulatory requirements.
3. Cross-Functional Collaboration
Work closely with European affiliate regulatory teams and internal departments to prepare registration submissions.
Liaise with EU regulatory authorities to ensure smooth dossier review and approvals.
Participate in company processes such as change control management, risk assessments, and reporting.
4. Leadership & Mentoring
Provide guidance and training to junior RA team members on dossier compilation, regulatory processes, and software used for regulatory operations.
Oversee maintenance of regulatory submission tools and software.
Support the development of standard operating procedures and regulatory best practices.
Required Qualifications and Experience
Degree in Pharmacy, Medicine, or Life Sciences.
Minimum 5 years of regulatory affairs experience, ideally in pharmaceutical formulations.
Strong experience in dossier compilation, marketing authorization applications, and maintenance.
Advanced knowledge of CTD dossier structure, EU registration procedures, and electronic submissions.
Excellent organizational, communication, and collaboration skills.
Proficiency in English; additional European languages are advantageous.
Preferred Qualifications
Advanced degree (Master’s or PhD) in a relevant field.
Regulatory Affairs Certification (RAC).
Hands-on experience with electronic regulatory submission systems.
Previous experience working directly with EU authorities and affiliates.
Why Join Us
Be part of a global consultancy with a strong European presence and industry recognition.
Lead and shape regulatory affairs initiatives for pharmaceutical formulations.
Collaborate with top professionals and industry leaders across Europe.
Work in a dynamic, supportive, and innovative environment.
Apply now to take your regulatory affairs career to the next level and make a significant impact in European pharmaceutical operations.
Explore more global regulatory affairs and pharmaceutical leadership roles at
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