{"id":3412157,"url":"https://alion.io/job/labconnect-senior-manager-regulatory-affairs","title":"Senior Manager, Regulatory Affairs","company":{"id":3854072,"name":"labconnect","domain":"labconnect.com","url":"https://alion.io/company/labconnect","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Dayforce","truth_index":{"grade":"A","score":86,"open_postings":4,"ghost_share":0,"stale_share":0.75,"repost_share":0,"time_to_fill_p50_days":11,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cologne, Germany"],"countries":["DE"],"hiring_countries":["DE"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":84000,"max_usd":164000,"period":"year","method":"role_seniority_country_cell","sample_n":9},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-28T04:00:00Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-11-01T04:32:19Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Job Summary\nThe 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.\nEssential Duties and Responsibilities\nSupport the Senior Director in developing and executing regional regulatory strategies for LabConnect initiatives within specific regions.\nContribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.\nCollaborate with cross-functional teams to integrate LabConnect considerations into process development, for clinical and real-world evidence studies.\nStay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director.\nContribute to managing regulatory risks and opportunities related to LabConnect projects and assist in developing mitigation strategies as needed.\nProvide regulatory guidance and support for clinical and post-marketing activities related to LabConnect projects.\nAssist in preparing regulatory updates, regulatory intelligence for governance committees.\nParticipates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the operations team in a timely and professional manner\n\nEducation and Experience\nBachelor's degree in scientific disciplines such as life sciences, pharmacy, bioscience; advanced degree preferred.\n7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on clinical research preferred.\n3+ years of people leadership experience required.\nStrong knowledge of regional regulatory requirements and guidelines, including country specific regulations and ICH guidelines.\n\nSkills and Ability\nLeadership, presence, judgement, communication, and client-engagement skills to effectively operate at the executive level.\nThrives in building highly effective teams; possesses strong people management skills.\nDemonstrated ability to work effectively in a cross-functional team environment.\nExcellent communication and interpersonal skills.\nAbility to assist in developing and executing regulatory strategies tailored to specific regions.\nStrong organizational skills with attention to detail.\nAbility to collaborate effectively with cross-functional teams.\nAwareness of regulatory developments and trends within specific regions.\nStrong analytical and problem-solving skills.\nAbility to work independently and prioritize tasks effectively.\n\nSupervisory Responsibilities: Manager\nPhysical Demands: \nWhile performing the duties of this job, the occupant is regularly required to:\nProlonged periods of sitting at a desk and working on a computer.\nProlonged use of computer and headphones for conference calls.\nCommunicate effectively via phone, video, and email.\nUse hands and fingers to operate a computer and other office equipment.\n\nTravel Requirements: Minimal\nOne Global Team\nAt 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.\nLabConnect 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.\n\nThis 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. 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