Assistant, Regulatory Affairs Europe- Remote

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 plays a pivotal role 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

• Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels

• Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools

• Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting

• Liaise with Finance requesting fee payment to Regulatory Authorities. Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action

What you will bring to the role

• Excellent written and verbal communication skills to clearly and concisely present information

• Good interpersonal skills in a fast-paced, deadline oriented, and changing environment

• Excellent ability to handle multiple tasks

Your background

• 2 years office/business experience in a supporting role

• Preferable CRO/pharmaceutical industry experience

• Bachelor’s degree or equivalent 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.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com 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.

Originally posted on Himalayas