Senior Manager, Regulatory Affairs

LabConnect; Köln; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

We live our values

Career growth opportunities

Strong team collaboration

Access to tools and resources

Job summary

LabConnect seeks a Senior Manager, Regulatory Affairs to safeguard the organization against regulatory and quality risks while ensuring efficient, compliant operations across global regulatory activities related to laboratory testing and clinical projects.

You will lead regional regulatory strategies, provide executive-level guidance, and collaborate with cross-functional teams to integrate regulatory considerations into study design and governance.

Qualifications

• Bachelor's degree in scientific disciplines such as life sciences, pharmacy, bioscience.
• 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.

Responsibilities

• Support the Senior Director in developing and executing regional regulatory strategies for LabConnect initiatives within specific regions.
• Provide strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional 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 regions, providing insights to the Senior Director.
• Help manage regulatory risks and opportunities related to LabConnect projects and develop mitigation strategies.
• Provide regulatory guidance for clinical and post-marketing activities related to LabConnect projects.
• Assist in preparing regulatory updates and governance-regulatory intelligence for committees.
• Facilitate communication and address questions from the operations team promptly and professionally.

Skills

Leadership

Strategic planning

Cross-functional collab

Regulatory knowledge

Communication

Independent work

Education

Bachelor's degree in life sciences

7+ years regulatory affairs experience

3+ years leadership

Knowledge of ICH guidelines

Job description

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

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 be one 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.

Some of the Perks our LabConnectors Love

• We truly live our values: People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always
• The opportunity to make a meaningful impact on a passionate and growing team
• Strong communication and collaboration within a smaller sized team
• Access to tools and resources that empower you to excel in your role

In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication.

We are proud to be an Equal Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic.

LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with the General Data Protection Regulation (GDPR). For this job posting, all hiring decisions are made with meaningful human involvement and consideration. In this context, no applicant is subject to a decision based solely on automated processing within the meaning of Article 22 of the GDPR.

To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/