Manager, Regulatory Affairs - EMEA- Remote

Worldwide Clinical Trials; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a Regulatory Affairs professional to lead submissions across EMEA, APAC and LATAM and support business development with regulatory input.

Roles include preparing technical documents, mentoring junior staff, and ensuring compliance with ICH GCP and country-specific requirements. Strong leadership and cross-cultural communication are essential for success in a global CRO environment.

Formación

• Bachelor’s degree or higher in medical/biological/health science or related field.
• 8+ years in clinical research (CRA/Reg Affairs) for life sciences roles.
• 5–7+ years in pharmaceutical/CRO with senior regulatory or start‑up experience.
• Proficient in cross‑cultural communication and English proficiency.

Responsabilidades

• Review budgets and costing, participate in negotiations, and attend bid defense meetings.
• Coordinate regulatory & ethics submissions across EMEA, APAC and LATAM and maintain approvals.
• Provide regulatory guidance and contribute to project work, communicate status with Sponsor and teams, prepare IMPDs/IBs.
• Mentor/coach junior staff; line management may be required.

Conocimientos

Leadership

Planning

Communication

Relationship-building

Interpersonal skills

Multitasking

Educación

Bachelor’s degree in life sciences or related field

Two-year college + life science degree with 8 years in clinical research

Descripción del empleo

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.

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 The 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

• Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
• Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
• Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements
• Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff

What You Will Bring To The Role

• Clearly, proven leadership and organizational management skills are essential attributes
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Excellent written and verbal communication skills to clearly and concisely present information
• Relationship-building competency combined with demonstrated comfort supporting Business Development at a face-to-face meeting
• Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

Your Experience

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
• Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience within clinical research (e.g., CRA, Reg Affairs)
• Minimum 5-7 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start‑up experience
• Proficient in cross‑cultural communication and proficient in both spoken and written English

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

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.