Regulatory Affairs Specialist

Worldwide Clinical Trials; Berlin; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A global clinical research organization seeks a Regulatory Affairs Specialist in Berlin, Germany. You will manage and submit regulatory documents, ensuring compliance with ICH GCP and other requirements. Strong organizational, communication, and regulatory experience are essential. Fluency in Danish and a degree in a related science field are required. This role contributes to improving lives through innovative medical product development, promoting a diverse and inclusive work environment.

Qualifikationen

• Fluency in Danish; working knowledge of English.
• Minimum three years of clinical research experience.
• Strong experience in the regulatory process under EU-CTR.

Aufgaben

• Liaise with colleagues to plan and submit regulatory submissions.
• Communicate status and action plans regarding submissions.
• Review relevant documentation for compliance with ICH GCP.

Kenntnisse

Organizational skills

Communication skills

Interpersonal skills

MS-Office proficiency

Ausbildung

Degree in medical, biological, physical, health, pharmacy or related science

Jobbeschreibung

Who we are

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.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

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.

Why Worldwide

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. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us.

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 three year of experience in clinical research, in site activation and / or regulatory-related function within a CRO.
• Candidates must have strong experience in the regulatory process in Denmark, specifically under the EU-CTR, to be considered for this role.
• Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations.
• Fluency in the Danish language is a mandatory requirement; working knowledge of English.

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

To view our other roles, check out our careers page at Discover a world of difference at Worldwide. For more information on Worldwide, visit or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.