Técnico/A Regulatory Affairs (Cosmética)

Affinis Selección De Personal & Headhunting; Barcelona; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

IQVIA seeks an experienced Regulatory Affairs professional to lead EU CTR/CTIS submissions and lifecycle activities. You will guide strategy, manage regulatory documentation, and liaise with authorities while mentoring juniors and supporting business development.

Ideal candidates have 8+ years in regulatory affairs within pharma/biotech/CRO sectors, with strong leadership and client-facing skills. Travel for meetings may be required.

Competenze

• Bachelor's Degree in Life Sciences or related field required.
• Master's Degree preferred; advanced regulatory expertise expected.

Mansioni

• Act as Regulatory Global Team Leader for regulatory projects.
• Lead preparation, review, and submission of regulatory docs.
• Provide strategic regulatory advice on EU submissions and lifecycle management.
• Lead EU CTR submissions and CTIS lifecycle activities.
• Manage communications with regulatory authorities and meetings.
• Build strong client relationships as regulatory advisor.

Conoscenze

Regulatory leadership

EU CTR/CTIS strategy

Regulatory submissions

Client advisory

Project management

Stakeholder management

Budget and timelines

Regulatory intelligence

Formazione

Bachelor's in Life Sciences

Master's in Life Sciences (preferred)

Strumenti

CTIS

Regulatory systems

Descrizione del lavoro

Madrid, Spain
Belgrade, Serbia
Lisbon, Portugal
Budapest, Hungary
Athens, Greece
Barcelona, Spain
Sofia, Bulgaria
Bucuresti, Romania
Full time
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Job Overview

Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.

Essential Functions

• Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand‑alone projects
• Lead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelines
• Provide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activities
• Lead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activities
• Manage communications and interactions with regulatory authorities, including support for and participation in agency meetings
• Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issues
• Manage project timelines, deliverables, budgets, and out‑of‑scope activities to ensure successful project execution and financial performance
• Mentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional development
• Support business development activities, including travelling to and participating in bid defense meetings and client presentations
• Contribute to the development, revision, and review of regulatory and cross‑functional Standard Operating Procedures (SOPs)
• Support global, regional, and cross‑functional regulatory initiatives and process improvement activities
• Remain current with regulatory intelligence, evolving regulations, and industry best practices
• Perform additional duties as assigned to support business and departmental objectives

Qualifications

• Bachelor's Degree in Life Sciences or a related discipline required
• Master's Degree in Life Sciences or a related discipline preferred

Experience

• Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industry
• Minimum of 2 to 3 years of hands‑on EU CTR and CTIS experience, including preparation, review, and submission of Part I initial Clinical Trial Applications (CTAs)
• Demonstrated experience managing CTIS lifecycle activities, including RFIs, substantial modifications, and ongoing trial maintenance
• Experience interacting with Reporting Member States (RMS) and other European regulatory authorities
• Proven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategy
• Advanced understanding of EU clinical trial regulations, guidance documents, and CTIS requirements
• Strong understanding of regulatory documentation requirements across different therapeutic areas, development stages, and product modalities
• Experience with combination product trials is advantageous
• Experience in regulatory strategy development, timeline planning, budget management, and documentation gap assessments
• Ability to independently manage multiple projects and priorities while meeting challenging timelines
• Strong project leadership and stakeholder management skills
• Excellent written and verbal communication skills, including preparation of high‑quality regulatory documents and client‑facing presentations
• Ability to establish and maintain effective relationships with clients, colleagues, and regulatory authorities
• Proficiency in Microsoft Office and relevant regulatory systems and publishing tools
• Applicable certifications and licenses as required by local regulations and business needs
• Willingness to support cross‑functional and global initiatives as required

Company Details

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.