Senior Manager, Regulatory Affairs

Labconnect,-LL; Köln; On-site; EUR 110,000 - 150,000; Full time

Job summary

LabConnect is seeking a Senior Manager, Regulatory Affairs to lead regulatory strategies and oversee a regional regulatory team. The role focuses on ensuring compliance across clinical trials and related laboratory activities, while guiding cross-functional partners through complex regulatory landscapes.

The ideal candidate brings 7+ years in regulatory affairs with leadership experience and a strong grasp of ICH guidelines, along with excellent communication at an executive level.

Qualifications

• Bachelor's degree in life sciences, pharmacy or bioscience; advanced degree preferred.
• 7+ years in regulatory affairs within pharma/biotech, with clinical research focus preferred.
• 3+ years of people leadership experience.
• Strong knowledge of regional regulatory requirements including ICH guidelines.

Responsibilities

• Support regional regulatory strategies for LabConnect initiatives within specific regions.
• Provide strategic oversight and leadership to the regulatory team.
• Collaborate with cross-functional teams to integrate regulatory considerations into development processes.
• Monitor regulatory developments and provide regional insights to leadership.
• Identify regulatory risks and mitigation strategies for LabConnect projects.
• Provide regulatory support for clinical and post-marketing activities.
• Prepare regulatory updates and governance materials.
• Coordinate communication and respond to questions from operations timely and professionally.

Skills

Leadership

Cross-functional

Regulatory strategy

Communication

Organization

Collaboration

Regulatory intelligence

Analytical thinking

Education

Bachelor's degree in life sciences / pharmacy / bioscience

Advanced degree preferred

Job description

Job Summary

The Senior Manager, Regulatory Affairs plays a critical role in safeguarding the organization against quality and regulatory risks. By ensuring that operations are both efficient and compliant, they will support the department maintain compliance with global regulatory and quality processes support of clinical trial and other projects operational activities related to laboratory testing.

Essential Duties and Responsibilities

• Support the Senior Director in developing and executing regional regulatory strategies for LabConnect initiatives within specific regions.
• Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.
• Collaborate with cross-functional teams to integrate LabConnect considerations into process development, for clinical and real-world evidence studies.
• Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director.
• Contribute to managing regulatory risks and opportunities related to LabConnect projects and assist in developing mitigation strategies as needed.
• Provide regulatory guidance and support for clinical and post-marketing activities related to LabConnect projects.
• Assist in preparing regulatory updates, regulatory intelligence for governance committees.
• Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the operations team in a timely and professional manner

Education and Experience

• Bachelor's degree in scientific disciplines such as life sciences, pharmacy, bioscience; advanced degree preferred.
• 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on clinical research preferred.
• 3+ years of people leadership experience required.
• Strong knowledge of regional regulatory requirements and guidelines, including country specific regulations and ICH guidelines.

Skills and Ability

• Leadership, presence, judgement, communication, and client-engagement skills to effectively operate at the executive level.
• Thrives in building highly effective teams; possesses strong people management skills.
• Demonstrated ability to work effectively in a cross-functional team environment.
• Excellent communication and interpersonal skills.
• Ability to assist in developing and executing regulatory strategies tailored to specific regions.
• Strong organizational skills with attention to detail.
• Ability to collaborate effectively with cross-functional teams.
• Awareness of regulatory developments and trends within specific regions.
• Strong analytical and problem-solving skills.Ability to work independently and prioritize tasks effectively.

Supervisory Responsibilities:

Manager

Physical Demands:

While performing the duties of this job, the occupant is regularly required to:

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.

Travel Requirements:

Minimal

One Global Team

At LabConnect, we are proud to beone global team: united by our shared mission to advance clinical trials through innovation, agility, and collaboration. We believe that our people are our greatest asset, and we are committed to fostering a workplace that reflects our core values: People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.

LabConnect is an Equal Opportunity Employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), creed, national origin, age, disability, genetic information, veteran status, or any other legally protected status. We are committed to cultivating a workplace that is safe, equitable, and respectful for all. Together, as one global team, we strive to ensure that every individual has the opportunity to thrive and contribute to our shared success.

This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job.