PROVEN PLACEMENTS. REAL IMPACT.

Our Recently Filled Positions showcase a snapshot of the impactful searches KBIC Life Sciences has successfully completed for clients across the life sciences industry. These placements reflect our deep market expertise, trusted relationships, and ability to connect organizations with high-caliber talent that drives innovation and growth.

Retained Search
Remote Position

My client is a global, commercial-stage biotech company at the forefront of antibody-drug conjugate (ADC) innovation. With a validated technology platform, approved therapies, and a robust pipeline targeting both hematologic and solid tumors, they are transforming the cancer treatment landscape.

Position: As the Vice President, Head of Global Regulatory Affairs, you will provide strategic and operational leadership across all regulatory functions to drive the company’s business objectives and ensure compliance with global health authority regulations. You will lead the planning and execution of critical regulatory milestones, including the preparation, review, and submission of INDs, BLAs, and other key filings.

Responsibilities:

  • Provide overall executive leadership and management in creating and executing global regulatory strategies for product development, approval, and registration, novel clinical trial designs, and support of future marketed products.
  • Develop and maintain regulatory knowledge of US, EU, and all global regulations.
  • Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial/marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.
  • Manage all activities pertaining to interactions with FDA, EMA, and all other global Health Authorities and communicate outcomes to Executive Leadership Team as requested.
  • Act as the primary regulatory representative and provide strategic regulatory guidance to project teams.
  • Lead the planning and preparation of global regulatory submissions (e.g., INDs, CTAs, Orphan Drug Applications, IND safety reports, meeting requests, and anticipated BLA submissions) and with partners as applicable.
  • Monitor and interpret global regulatory policy developments (e.g., FDA, EMA, ICH, WHO) relevant to Oncology product development.
  • Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies.
  • Serve as the liaison between the company and FDA and other global regulatory authorities for assigned projects.
  • Lead the Global Regulatory Affairs organization by recruiting, retaining, and developing staff.
  • Establish and manage all regulatory timelines with the Global Project Manager.
  • Responsible for the Global Regulatory Affairs organization, meeting corporate goals and objectives, and keeping in compliance with applicable global policies and regulations.
  • Management of, and collaboration with, CRO partners for regulatory submissions and other regulatory activities as needed.

Experience/Qualifications:

  • M.D., Ph.D., or Pharm D. degree is preferred, along with 15 years or more of experience in regulatory affairs
  • Strong knowledge and experience with regulatory affairs and FDA regulations, with knowledge of other key regions, including EU and other international regulatory affairs (e.g., Japan and China)
  • Hands-on experience in leading clinical trials, Phase I-IV.
  • Demonstrated success in leading and executing regulatory strategy from preclinical through development stage.
  • Significant track record of successful interactions with US, EU, and other global regulatory agencies, as demonstrated by timely submissions, management of health authority requests, and approvals of drugs/biologics.
  • Experience in oncology and/or hematology preferred
  • Experience with bio-pharmaceuticals is desirable
  • Possess good verbal and written communication skills
  • Must be able to work in an agile, small company environment, optimize resource allocation, and be very hands-on in the completion of day-to-day work.
  • Ability to interact effectively across boundaries with other global functions.
  • Strong leadership in representing Regulatory Affairs positions to Executive Leadership Team.

#regulatoryaffairs #oncology #hematology #antibodydrug conjugate #regulatorystrategy #executiveleadership

My client is a global clinical-stage biopharmaceutical organization developing innovative therapies for immunologic diseases with significant unmet medical needs.

They are seeking a highly skilled and detail-oriented Associate Director of Regulatory Operations to join their growing team. This individual will play a critical role in U.S. Biologics License Application (BLA) preparation, submission, and defense, while driving cross-functional collaboration and ensuring compliance with global regulatory standards.

This is an exceptional growth opportunity to join a mission-driven team pioneering next-generation therapies for patients worldwide and to play a vital role in bringing transformative treatments to market.

Responsibilities:

  • Lead project management and execution of major U.S. and global regulatory submissions (BLA, IND, MAA).
  • Develop and maintain comprehensive Global Submission Plans, timelines, and dossier tracking.
  • Coordinate publishing activities with external e-publishing vendors for all submission deliverables.
  • Manage all regulatory submission preparation and archiving activities within Veeva RIM.
  • Serve as a system expert supporting, training, and guiding users across regulatory and cross-functional teams.
  • Collaborate with partners across CMC, Clinical, Nonclinical, and Labeling to ensure timely, accurate submissions.
  • Support FDA Advisory Committee preparation and post-submission activities with Health Authorities.
  • Monitor regulatory intelligence and implement process improvements to enhance efficiency and compliance.

Experience/Qualifications:

  • Must Have Proficiency in Veeva RIM, including document management, tracking regulatory commitments, and user training is required.
  • Bachelor’s degree in Life Sciences (advanced degree preferred).
  • 5+ years of Regulatory Operations experience within biotech or pharmaceutical industries
  • (biologics experience strongly preferred).
  • Proven success in preparing and submitting BLA and IND applications.
  • Deep understanding of global regulatory submission requirements and eCTD standards.
  • Experience supporting FDA Advisory Committee preparation preferred.
  • Strong communication, technical writing, and project management skills.

#regulatoryoperations #regulatoryaffairs #veeva #veevarim #regulatorysubmissions #eCTD

My client is a global clinical-stage biopharmaceutical organization developing innovative therapies for immunologic diseases with significant unmet medical needs. They are seeking a Head of Global Regulatory CMC to join their growing team.

Position: In this role, you will provide strategic leadership for the global regulatory efforts, guiding the development and execution of CMC strategies for complex biologic and drug-device combination products. The Head of Global Regulatory CMC will be responsible for authoring and driving submissions of critical regulatory documents, including IMPDs, INDs, BLAs, NDAs, CTAs, FDA briefing packages, and MAAs, ensuring the highest quality and compliance standards.

RESPONSIBILITIES:

  • Point of contact for regulatory CMC expertise at health authority meetings and interactions.
  • Prepare Module 3s of BLAs and MAAs for drug/device (patch) combination products for food allergies and prepare the CMC sections of INDs and IMPDs for early-stage products.
  • Develop and coordinate CMC submissions to regulatory authorities, monitor progress, and coordinate written and verbal (during meetings) responses.
  • Provide leadership, support, and expertise in preparing and finalizing all necessary manufacturing documents in support of IND, BLA, NDA, MAA, and other critical applications.
  • Review CMC-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and as appropriate for the phase of development.
  • Closely Partner with internal stakeholders and external CDMOs/testing facilities to maintain inspection readiness and operational excellence.
  • Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
  • Monitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications to current and future development and commercial activities.

EXPERIENCE/QUALIFICATIONS:

  • Bachelor’s degree in life sciences or equivalent discipline is required; an Advanced degree (MS, PhD, PharmD) is strongly preferred. US RAC certification is a plus.
  • Minimum of 10 years’ experience working in a regulatory CMC function with direct responsibility for leading regulatory strategy, writing key documents (e.g., FDA briefing books, IMPD, IND, BLA, NDA), and directly interfacing with health authorities (i.e., FDA, EMA).
  • Critical ability to work closely with in-house Subject Matter Experts (SMEs) and Contract Manufacturing Organizations (CMOs) to acquire critical information in support of preparing the various segments of Module 3 and responses to Health Authority questions and issues.
  • Demonstrated ability to supervise a Regulatory CMC staff and contract CMC Regulatory writers.
  • Major capability to set, monitor, and meet CMC Module 3 and other Regulatory CMC timelines and deadlines.
  • Experience in working with CMC Regulatory formats and templates for eCTD compilation of information and data displays.
  • Prior experience participating in and writing documents for the FDA and other Health Authorities is required.
  • Direct experience developing early and late-phase programs for combination products, biologics, and/or innovative technologies.
  • Direct experience participating in cross-functional teams in a matrix environment.
  • Experience working in both large pharmaceutical and small biotechnology organizations.
  • Experience in building and managing a team of regulatory professionals.
  • Experience providing strategic regulatory CMC guidance to drug development, registration, and post-market support teams.
  • Broad familiarity and current working knowledge of GxP (i.e., GMP, GDP, GCP).
  • Understanding and working experience with biological products, combination products, and innovative products in early and late-phase clinical development.

#cmc #regulatorycmc #regulatoryaffairs #module3 #biologics #briefingpackages #fda #drugdevice #combinationproducts

Our client is a leading innovator in medical device technology, specializing in cutting-edge, laser-powered solutions that advance patient care. Their mission is to push the boundaries of what’s possible in healthcare through groundbreaking innovation, precision engineering, and a deep commitment to improving clinical outcomes.

If you’re passionate about making a real impact in the world of medical technology, this is your opportunity to join a purpose-driven team that’s shaping the future of healthcare one innovation at a time.

Position: In this role, you will be responsible for managing large-scale, highly complex, multi-faceted new medical product development programs, involving internal and external development partners.

Responsibilities:

  • Plans and directly manages cross-functional projects that may include external resources and contracted companies.
  • Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.
  • Proactively identify and assess areas of risk, escalate issues promptly, and proactively propose solutions.
  • Partners with development team members to drive accountability and high quality of project tasks and deliverables.
  • Continuous prioritization of team member activities and follow-up on actions.
  • Manages program budgets, generates forecasts, and tracks actuals against projections.
  • Monitors progress against the plan and implements corrective actions or contingencies as needed to maintain commitments.
  • Provides management with regular project status, plan variances, and corrective action identification.
  • Works closely with functional management to gain resource commitments and resolve issues.
  • Provides input to directors/managers and senior management on team member performance.
  • Effectively manages performance issues and conflicts.
  • Oversees and facilitates compliance with design control and product development processes.

Experience/Qualifications:

  • MS degree in an Engineering discipline or higher.
  • Advanced skills in project management, project reporting, and presentations.
  • 8+ years of project management experience in one of the following areas: Class II electro-mechanical medical devices, electro-opto-mechanical systems, optics-based medical devices (Laser-based systems, Preferred)
  • 10+ years of technology development experience in one of the following areas: laser systems, electro-opto-mechanical systems, optics-based medical devices.
  • Track record of executing complex multi-functional projects on time and within budget.
  • Ability to manage multiple projects in a fast-paced development environment.
  • Proven experience working within a controlled product development process.
  • Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR’s, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.

#medicaldevice #regulatoryaffairs #510(k) #classII #electromechanical #newposition #ISO13485 #EU #executiverecruitment #laser #NPD

My client is a leading innovator in medical device technology, specializing in cutting-edge, laser-powered solutions that advance patient care. Their mission is to push the boundaries of what’s possible in healthcare through groundbreaking innovation, precision engineering, and a deep commitment to improving clinical outcomes.

Position Summary: The Quality Engineering Manager will lead a team of quality engineers and specialists to ensure that all medical device products meet regulatory requirements, quality standards, and customer expectations.

Responsibilities:

  • Provide manufacturing quality engineering leadership to manufacturing and sustaining engineering.
  • Manage direct reports by providing direction, mentorship, and growth opportunities
  • Report on the Manufacturing and Quality KPIs
  • Conduct product design control activities for new and sustaining product development efforts
  • Support risk analysis activities, including design and process FMEA
  • Participate in quality-driven supply chain activities.
  • Participate in the reliability/customer complaint team meetings.
  • Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities
  • Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications for in-house / external manufacturing
  • Prepare for and participate in internal and external audits with notified bodies and customers
  • Perform other duties as assigned to support the advancement of the QMS and product manufacturing.

Experience/Qualifications:

  • Bachelor’s degree in science, engineering, or other related technical discipline.
  • 10+ years of experience in medical device quality engineering.
  • Extensive experience in quality management within the medical device industry.
  • Solid understanding of medical device ISO 13485, FDA 21 CFR 820.
  • Familiar with MDR (EU) 2017/745/MDD, ISO 14971
  • Experience with intravascular catheters and/or electro-mechanical hardware.
  • Medical device software experience is a plus.
  • Experience with sterile products is preferred.

#medicaldevice #regulatoryaffairs #510(k) #classII #electromechanical #newposition #ISO13485 #EU #executiverecruitment #laser #qualityassurance

Our client is a leading innovator in medical device technology, specializing in cutting-edge, laser-powered solutions that advance patient care. Their mission is to push the boundaries of what’s possible in healthcare through groundbreaking innovation, precision engineering, and a deep commitment to improving clinical outcomes.

If you’re passionate about making a real impact in the world of medical technology, this is your opportunity to join a purpose-driven team that’s shaping the future of healthcare one innovation at a time.

Position: As a Regulatory Affairs Specialist, you will play a crucial role in supporting the Medical Device Development team in achieving its mission by navigating and ensuring compliance with global regulatory requirements. In this role, you will collaborate closely with the Director of Regulatory Affairs to secure and maintain international regulatory approvals, contributing directly to my client’s success in marketing their state-of-the-art medical devices worldwide. This position offers a unique opportunity to grow in the Medical Device regulatory field and significantly improve patient outcomes.

Responsibilities:

  • Prepare and submit global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510ks, IDEs, and applicable supplements and annual reports), Canadian Class 3 Device License submissions, EU MDR Submissions, and other international markets such as Japan, Saudi Arabia, Australia, and Brazil.
  • Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
  • Assess design and manufacturing changes for compliance with applicable regulations and effect on registrations.
  • Maintain regulatory files and tracking databases as needed.
  • Support quality system audits by notified bodies, government agencies, and customers.
  • Obtain Medical Device Certificates to Foreign Government (CFGs).
  • Support post-market surveillance, including preparation of post-market clinical follow-up plans and reports. Participate in reviewing complaints and all other post-market-release feedback.
  • Submit medical device reports. Support Unique Device Identifier activities.

Experience/Qualifications:

  • Bachelor’s degree or equivalent work experience, preferably in an engineering or life sciences discipline.
  • 2-5 years of hands-on experience in a Medical Device organization.
  • Direct experience with regulatory submissions and management of Class II electro-mechanical medical devices.
  • Regulatory affairs experience in generating applications and experience in collaboration with internal and external partners to answer any subsequent questions.
  • Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSRs, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366.
  • Experience with lasers and optical technologies is desired but not necessary.
  • Strong working knowledge of Microsoft Word and Excel.

#medicaldevice #regulatoryaffairs #510(k) #classII #electromechanical #newposition #ISO13485 #EU #executiverecruitment #laser

Location: Remote

Duration: 6–12 months, with potential for extension

Reports To: Senior Vice President, Head of Early Development

Position: My client is seeking a highly experienced Senior Regulatory Strategy & Regulatory Policy Consultant with deep expertise in oncology and small-molecule drug development. The ideal candidate will have a strong track record of successful interactions with the FDA, including pre-IND meetings, IND submissions, and the development of regulatory strategies throughout the product lifecycle. This individual will also serve as a thought leader on regulatory policy and intelligence, providing strategic input to cross-functional teams.

Responsibilities:

  • Lead and execute regulatory strategy for oncology programs involving small-molecule therapeutics, from preclinical through development phases.
  • Prepare, review, and submit high-quality regulatory documents (e.g., INDs, briefing books, meeting requests, amendments).
  • Support cross-functional teams (Regulatory Affairs, Clinical, Legal, Government Affairs) in aligning business objectives with regulatory policy landscapes.
  • Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial/marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.
  • Monitor and interpret global regulatory policy developments (e.g., FDA, EMA, ICH, WHO) relevant to Oncology product development.
  • Act as the primary liaison with FDA and other regulatory authorities; manage and participate in formal regulatory meetings.
  • Provide expert guidance on current regulatory policies, including the interpretation of FDA guidance and industry trends that impact the development of oncology drugs.
  • Support cross-functional teams (Clinical, CMC, Safety, Commercial) to ensure regulatory alignment with overall development objectives.
  • Monitor changes in the regulatory landscape and ensure compliance with applicable regulations and guidance.
  • Assist in the development of internal regulatory procedures and best practices.
  • Provide mentorship to junior regulatory staff or clients as needed.

Experience/Qualifications:

  • An advanced degree (PhD, PharmD, MS, or equivalent) in a life science discipline is preferred.
  • Minimum of 10 years of experience in Regulatory Affairs, with a focus on oncology and small-molecule drug development.
  • Extensive experience engaging in industry advocacy through participation in trade associations, regulatory working groups, and public comment processes.
  • Proven problem-solving mindset with the ability to think strategically and creatively to address complex regulatory challenges and advance development goals.
  • Demonstrated success in leading FDA submissions and regulatory agency interactions, including face-to-face and teleconference meetings.
  • Deep knowledge of FDA regulations, guidance documents, and regulatory policy relevant to oncology drug development.
  • Experience with global regulatory requirements (e.g., EMA, Health Canada) is a plus.
  • Strong project management, communication, and leadership skills.
  • Ability to work independently in a dynamic, fast-paced environment.

#regulatoryconsultant #regulatoryaffairs #oncology #smallmolecule #regulatorystrategy #drugdeveopment #policy