Manager, Regulatory Affairs (EMEA)

Worldwide Clinical Trials; Warszawa; On-site; PLN 210,000 - 320,000; Full time

Job summary

Worldwide Clinical Trials is seeking an experienced Regulatory Affairs professional to lead complex submissions across EMEA, Asia Pacific and LATAM. You will mentor junior staff, provide strategic guidance on regulatory projects, and collaborate with sponsors and cross-functional teams to ensure regulatory success.

The role requires a strong background in medical/science education, extensive regulatory know-how, and ability to navigate diverse regulatory environments while maintaining

Qualifications

• Minimum four-year college curriculum in medical/biological/physical/health sciences or related field.
• Two-year college curriculum with eight years of clinical research experience (e.g., CRA, Reg Affairs).
• 5–7 years in pharmaceutical/CRO industry with senior regulatory or start-up experience.
• Proficient in cross-cultural communication and English (spoken and written).

Responsibilities

• Review study budgets and costing related to contract negotiations and bid defense meetings.
• Coordinate and manage regulatory and ethics submissions across EMEA, Asia Pacific and LATAM regions.
• Provide expert regulatory advice and communicate submission status with Sponsor, Project Manager, CRAs and Medical & Scientific Affairs staff.
• Train, coach and mentor junior staff; line management may be required.

Skills

Leadership

Regulatory affairs

English proficiency

Cross-cultural communication

Education

Bachelor's degree in life sciences

Two-year college curriculum in life sciences with 8 years of clinical research experience

Job description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

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

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.