Senior Manager, Regulatory Affairs - Europe - remote

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.

• Review study budgets and costing for 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 and manage regulatory and ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions, ensuring 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.

• Clearly proven leadership and organizational management skills.
• 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.

• 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.

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.