Senior Regulatory Affairs Specialist - EU- Home Based

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.

What the Regulatory Affairs Department does at Worldwide: Regulatory Affairs is pivotal in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission process.

What you will do:

• Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis.
• May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
• Where required provide local QC of submission dossiers prior to dispatch.
• Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions.
• Identify risks and generate mitigation strategies.
• When possible, foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers.
• Maintain country specific patient information sheet and consent form customization text.
• Maintain country specific drug labeling information.
• Maintain Country Intelligence Pages.
• Be familiar with and comply with SOPs, ICH GCP and applicable regulations.
• Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database.
• Advise the SAR project team about appropriate regulatory strategies.
• Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements.
• Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department.
• Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives.

What you will bring to the role:

• Strong organizational and management skills.
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
• Self-motivated learning about current regulatory processes and intelligence.
• Excellent written and verbal communication skills to clearly and concisely present information.
• Team-oriented work style; seeks and gives guidance to others.
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.
• Excellent ability to handle multiple tasks in a fast-paced and changing environment.
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint.
• Aptitude for contemporary digital systems is helpful.

Your experience:

• Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science.
• Minimum 3 years of experience in clinical research, in site activation and/or regulatory-related function within a CRO.
• To be considered for this role, candidates must have experience with the regulatory process in the UK and under EU-CTR.
• Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations.
• Multilingualism preferred; fluent in local language; working knowledge of English.

We love knowing that someone is going to have a better life because of the work we do.