Senior Regulatory Specialist (CP53HM923)

Cmed Group Ltd; Madrid; A distancia; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading international Contract Research Organization (CRO) is seeking a Senior Regulatory Specialist. This role involves regulatory document preparation and strategy development to support clinical trials, providing guidance to various internal teams, and ensuring compliance with global regulations. Ideal candidates will have extensive regulatory experience, strong communication skills, and the ability to work independently.

Formación

• Minimum 5-7 years of regulatory affairs experience in pharmaceutical, biotech, or CRO.
• Strong understanding of global regulatory requirements (FDA, EMA, ICH).
• Demonstrated ability to interact effectively with regulatory authorities.

Responsabilidades

• Lead planning and submission of regulatory documents for global clinical trials.
• Develop regulatory strategies aligning with project objectives.
• Provide regulatory guidance to cross-functional teams.

Conocimientos

Project Management

Regulatory Compliance

Communication

Problem Solving

Educación

Bachelor’s degree in life sciences

Advanced degree (preferred)

Descripción del empleo

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

We are currently looking for an enthusiastic and talented Senior Regulatory Specialist. This role can be home-based in the UK or EU where we have the ability to hire.

Key Responsibilities:
• Lead the planning, preparation, review and submission of regulatory documents for global clinical trials (INDs, CTAs, amendments, annual reports, etc.) in compliance with international regulations (FDA, EMA, MHRA, etc.).
• Develop and execute regulatory strategies to support clinical development plans, ensuring alignment with project objectives and timelines.
• Serve as the primary regulatory contact for sponsors, internal teams and regulatory agencies.
• Provide regulatory guidance to cross-functional teams, including clinical operations, pharmacovigilance, data management and biostatistics.
• Monitor and interpret global regulatory requirements and changes, proactively communicating their impact on ongoing and planned projects.
• Support the preparation of investigator brochures, clinical trial protocols, informed consent forms and other essential documents.
• Manage interactions with regulatory authorities, including the preparation of briefing documents and participation in regulatory meetings.
• Participate in Bid Defense Meetings and proposal development, providing regulatory expertise and strategy insights.
• Maintain regulatory compliance and ensure consistency, accuracy and scientific integrity of submissions.
• Contribute to the development of departmental processes, templates and best practices.
• Provide mentorship and regulatory training to internal staff as needed.

Qualifications:
• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related field; advanced degree preferred.
• Minimum 5-7 years of regulatory affairs experience in the pharmaceutical, biotechnology or CRO environment.
• Strong understanding of global regulatory requirements (FDA, EMA, ICH, and other international guidelines) and clinical trial processes.
• Experience preparing and managing regulatory submissions across multiple phases of clinical development.
• Demonstrated ability to interact effectively with regulatory authorities and cross-functional teams.
• Excellent project management, organizational, and communication skills.
• Proactive, solution-oriented, and able to work independently in a fast-paced environment.

For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.