Regulatory Affairs Specialist - Montenegro -Contractor -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 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

• You will be a subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation and maintenance for awarded projects.
• You will be responsible for planning, initiating, and tracking documents required for regulatory submissions, essential documents collection, review, and provision of country/site/EC requirements to support the achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable.

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
• Proactive by identifying potential issues in the process and anticipating solutions
• Thorough understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
• Easily adjusts to a changing environment; ability to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality
• Team-oriented work style; seeks and gives guidance to others

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 experience of the regulatory process in the UK/ and/or under EU-CTR (Poland, Denmark) to be considered for this role.
• 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.

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