regulatory specialist

Semmes Murphey Foundation

<div>Description: The Semmes Murphey Foundation, affiliated with Semmes Murphey Clinic, is an independent, research-focused, public benefit corporation (501(c)3) dedicated to advancing innovation and excellence in neuroscience. We are growing our clinical research department and looking to add new talent to our team.<br>
This role provides our Foundation with critical regulatory support across various industry-sponsored clinical trials, PI-initiated and grant-funded studies, and quality registries. You will ensure regulatory compliance, timely IRB submissions, document control, and audit-ready study files throughout the lifecycle of clinical research projects.<p><b>
Essential Duties and Responsibilities:</b></p><ul><li>
Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures</li><li>
Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence</li><li>
Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track</li><li>
Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies</li><li>
Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files</li><li>
Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol</li><li>
Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager</li></ul>
Requirements:
<p>
MINIMUM:</p><ul><li>
Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field</li><li>
Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities</li></ul><p>
PREFERRED:</p><ul><li>
Five plus years of clinical research regulatory experience</li><li>
Master's degree in related field</li><li>
Professional certifications such as CCRC (ACRP) or CCRP (SOCRA)</li><li>
Experience supporting multi-site or industry-sponsored clinical trials</li></ul><p>
Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail.</p><p><br>
</p><p>Equal Opportunity Employer/Veterans/Disabled</p><p>
#SMF</p></div>

Clinical Research Regulatory Specialist

University of Southern California

<div><p>The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the &quot;Trojan Family,&quot; which is comprised of the faculty, students and staff that make the university what it is.</p><p></p><p><b>
JOB ACCOUNTABILITIES:</b></p><ul><li><p>
Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Submits protocols and supportingdocuments to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.</p></li><li><p>
Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Manages and maintains CISO electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations.</p></li><li><p>
Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed.</p></li><li><p>
Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.</p></li><li><p>
Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.</p></li><li><p>
Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial progress.</p></li><li><p>
Participates in KSOM centralized activities to support and promote research regulatory requirements. Coordinates with and assists other CISO staff and departments with educational efforts, helping ensure highest quality research and protection of human subjects. Identifies compliance training and educational needs, coordinates the reporting of serious adverse events and protocol deviations, and proposes, completes, and submits amendments to protocols and trial forms and documentation, as needed.</p></li><li><p>
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.</p></li></ul><p></p><p><b>
Position location:</b> On-site</p><p></p><p><b>
Salary range:</b></p><p>
The annual rate for this position is $75,968.95 - $101,364.43. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.</p><p></p><p>
USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.</p><br>
<p></p>
Minimum Education: Bachelor's degree Minimum Experience: 2 years/Combined education/experience as substitute for minimum experience Minimum Field of Expertise: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and diverse individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g. Google suite, Slack, Skype). Preferred Education: Bachelor's degree Preferred Experience: Three years Supervises: No Preferred Field of Expertise: Three years&rsquo; experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research. Special Instructions to Applicants: Applicant Attachments (Required): R&eacute;sum&eacute; &amp; Cover Letter Applicant Questions: N/A Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Updates all databases, and regulatory binders with information pertinent to studying milestone progress. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.</div>

EVA pharma

<div>
 <p>
  Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
  <br/>
  &nbsp;
 </p>
 <p>
  <strong>
   Job Summary:
  </strong>
 </p>
 <p>
  We are seeking a passionate and talented
  <strong>
   Regulatory Affairs Specialist
  </strong>
  to join our dynamic team.
 </p>
 <p>
  The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
 </p>
 <p>
 </p>
 <p>
  <strong>
   Key Responsibilities:
   <br/>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   Regulatory Compliance - Ensure all products meet international regulations, serving as the primary regulatory contact for our international hubs
  </li>
  <li>
   Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
  </li>
  <li>
   Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
  </li>
  <li>
   Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
  </li>
  <li>
   Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
   <br/>
  </li>
 </ul>
 <p>
  <strong>
   Qualifications:
   <br/>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   Bachelor's degree in Pharmaceutical Sciences
  </li>
  <li>
   +2 years of experience in Regulatory Affairs in international Markets.
  </li>
  <li>
   Fluent in English (written &amp; verbal) - essential for global collaboration
  </li>
  <li>
   Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
  </li>
 </ul>
 <p>
 </p>
</div>


Regulatory Affairs Specialist

Biogen

<div><p><i>This is a remote-based position, candidate must be located within the USA
</i></p><div><div><div><div><div><div><div><div><div><p><i>Must be available to start work daily by 9AM EST
</i></p></div></div></div></div></div></div></div></div></div><p></p><p><b>About This Role
</b></p><p>The Medical Writing Redaction/Regulatory Response Specialist leads and executes redaction activities for clinical documents intended for public disclosure, ensuring compliance with global requirements and supporting Medical Writing in delivering high-quality redacted packages. The role also provides essential support for regulatory responses by organizing background materials, drafting and formatting response documents, coordinating cross-functional reviews, and ensuring alignment with internal standards and health authority expectations.
</p><p></p><p>The Specialist reports to the Associate Director of Medical Writing Operations and is a is a core member of the Medical Writing Operations structure, contributing to both document delivery excellence and broader clinical submission readiness.
</p><p></p><p><b>What You&rsquo;ll Do
</b></p><ul><li><p>Serve as the subject-matter expert on global redaction regulations and evolving health authority expectations
</p></li><li><p>Manage redaction of clinical documents in line with EMA Policy 0070, Health Canada PRCI, EU CTR, and other global requirements and oversee timely delivery of redaction workflows
</p></li><li><p>Maintain and update CCI redaction trackers across programs
</p></li><li><p>Assess internal and external technology solutions to improve redaction processes
</p></li><li><p>Support audits and inspections related to redaction activities
</p></li><li><p>Support Regulatory teams in preparing health authority responses (e.g., FDA, EMA, PMDA, Health Canada) by coordinating document collection, background materials, cross-functional input, and ensuring timely, compliant submissions
</p></li><li><p>Format, compile, and assemble response packages with consistency, clarity, and adherence to submission standards
</p></li><li><p>Assist Regulatory Leads with fact-checking and enhancing grammar, clarity, and flow of response documents
</p></li></ul><p></p><p><b>Who You Are
</b></p><p>You are an insightful, customer-focused professional who collaborates effectively across diverse teams. You manage multiple priorities well, deliver high-quality work in dynamic environments, and bring strong organizational skills. You consistently demonstrate integrity, agility, and a positive approach in a fast-paced, compliant setting.
</p><p></p><p><b>Required Skills
</b></p><ul><li><p>Minimum bachelor&rsquo;s degree, Life or Health Sciences preferred
</p></li><li><p>7+ years of experience in redaction operations, Medical Writing Operations, and/or regulatory affairs in the pharmaceutical industry
</p></li><li><p><b>Strong understanding of global redaction requirements (EU CTR, Policy 0070, PRCI, etc.)
</b></p></li><li><p>Exceptional attention to detail and strong written communication skills
</p></li><li><p>Ability to work under tight timelines with high quality and minimal supervision
</p></li><li><p>Strong organizational, timeline management, and cross-functional collaboration abilities
</p></li><li><p>Proficient with major Microsoft suite programs
</p></li><li><p>Experience in leading regulatory meetings
</p></li></ul><p></p><p><b>Preferred Skills
</b></p><ul><li><p>Project management experience
</p></li></ul><p></p><p><b>#LI-Remote<br>
</b></p><p></p><br>
Job Level: Management<br>
<p><br>
<b>Additional Information
</b></p><p></p>The base compensation range for this role is: $126,000.00-$176,000.00<br>
<div><p><br>
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills &amp; experience, job location, and internal equity.
</p><p></p><p>Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
</p><p></p><p>In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees&rsquo; and their families <i>physical, financial, emotional, </i>and <i>social well-being </i>; including, but not limited to:
</p><ul><li>Medical, Dental, Vision, &amp; Life insurances
</li><li>Fitness &amp; Wellness programs including a fitness reimbursement
</li><li>Short- and Long-Term Disability insurance
</li><li>A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
</li><li>Up to 12 company paid holidays + 3 paid days off for Personal Significance
</li><li>80 hours of sick time per calendar year
</li><li>Paid Maternity and Parental Leave benefit
</li><li>401(k) program participation with company matched contributions
</li><li>Employee stock purchase plan
</li><li>Tuition reimbursement of up to $10,000 per calendar year
</li><li>Employee Resource Groups participation
</li></ul></div><p></p><div><p><b>Why Biogen?
</b></p><p>We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
</p><p></p><p>At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&amp;I efforts.
</p><p></p><p>All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.</p></div></div>

Clinical Trials Redaction/Regulatory Response Specialist

Northeastern University

<div><p><b>About the Opportunity
</b></p><p></p><p><b>Job Summary
</b></p><p>We invite applications for Part-time Lecturer (PTL) positions at the graduate level. We seek a colleague with an interest in teaching the BIOT 5830 - Regulatory Landscape of Cell and Gene Therapies for the Cell and Gene Therapy Master&rsquo;s Programs, depending on program needs and enrollment. The course introduces the current state of regulatory approvals for cell and gene therapies, with a focus on scientific and technical considerations for approval in the United States, Europe, and other key global markets. It explores scientific challenges in the regulatory approval process, differences from traditional biotherapeutic approvals, and evolving pathways emphasizing quality, efficacy, and safety throughout the product lifecycle, from manufacturing to commercialization.
</p><p></p><p><b>Key Responsibilities
</b></p><p>The Part-time Lecturer will review and learn key teaching points within existing materials, prepare and deliver lectures based on provided course content, and facilitate in-person or online class discussions that encourage active learning and respectful debate. They will guide students through case studies and real-world examples in regulatory approval, provide timely feedback, grading, and coaching to support student learning, and maintain consistent engagement with students regarding their performance and progress. In addition, the instructor will adhere to Northeastern University policies and program standards.
</p><p></p><p>Part-time instructors work under the direction of the program director and will hold office hours as appropriate.
</p><p></p><p><b>Qualifications
</b></p><p>The ideal candidate will hold a Ph.D. or equivalent graduate degree in a closely related field, with at least five years of work experience in biotechnology, biopharma, or a related industry. Proven presentation and instructional platform skills are required, along with an open and supportive professional style and willingness to receive assistance and coaching from faculty when needed.
</p><p>Prior experience in a diverse higher education institution is preferred.
</p><p><b>Documents to Submit
</b></p><ul><li>CV/resume
</li></ul><ul><li>Cover letter
</li></ul><ul><li>Statement of teaching experience
</li></ul><ul><li>Three references (include name, title, company, phone, email, and relationship, e.g., current supervisor)
</li></ul><p></p><p><b>Position Type
</b></p><p></p>Academic
<p></p><p><b>Additional Information
</b></p><p></p><p>Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.
</p><p></p><div><div><div><div><p>Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness &amp; life, retirement- as well as commuting &amp; transportation. Visit https://hr.northeastern.edu/benefits/ for more information.
</p></div></div></div></div><p></p><p>All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.
</p><p></p><p><b>Pay Range:</b></p></div>

Part Time Lecturer, Regulatory Landscape of Cell & Gene Therapies

Global Software Resources

<p><div><div><div><div><b>Job Title: IT Audit And </b><b>Compliance Project Specialist</b>
<br>
<b>Location: </b>Oakland<b>, </b>CA<br>
<b>Duration: </b>May 04, 2026<b> </b>&ndash; November 03, 2026,
<br>
<b>ONLY W2 Candidate</b></div>
</div><br>
</div></div><div><div><div><div><b>Account Manager Notes: </b>Hybrid Onsite Requirement: 1-2 days onsite depending on need for that week</div>
</div><br>
</div></div><div><div><div><div><b>Job Description:
</b><br>
<b>Role Overview</b><br>
<br>
The IT Compliance Project Specialist acts as a compliance and governance partner across the IT project portfolio. This role ensures that IT initiatives are planned, designed, and delivered in compliance with applicable regulations, company policies, and compliance standards.<br>
<br>
Working closely with the Compliance Lead, the Specialist provides analysis, documentation, and due diligence to support risk-based decision-making and to maintain compliance throughout the full project lifecycle.<br>
<br>
<b>Key Responsibilities</b><br>
<br>
Project Advisory &amp; Engagement
<ul><li>Serve as a dedicated compliance advisor to project managers and delivery teams.</li>
<li>Identify regulatory, policy, and control requirements early in the project lifecycle and ensure they are embedded into technical designs and project plans.</li>
</ul>Gate Review &amp; Approval Support
<ul><li>Participate in project phase-gate reviews to assess compliance readiness.</li>
<li>Review project artifacts and provide formal recommendations to the Compliance Lead to support approval, conditional approval, or remediation decisions.</li>
</ul>Compliance Lead Support
<ul><li>Function as the primary support resource for the Compliance Lead.</li>
<li>Assist with executive reporting, remediation tracking, and escalation of project-level compliance risks.</li>
</ul>Regulatory &amp; Framework Alignment
<ul><li>Ensure project alignment with applicable regulations and frameworks, including SOX, CCPA, ISO 55001, and internal company standards.</li>
<li>Map project controls and artifacts to regulatory requirements to support a consistent and defensible compliance posture.</li>
</ul><b>Qualifications</b><br>
Experience
<ul><li>5+ years of experience in IT Compliance, IT Audit, or Governance, Risk &amp; Compliance (GRC), preferably supporting large-scale IT projects.</li>
</ul><b>Tools &amp; Systems</b>
<ul><li>Experience using Planisware for project tracking, portfolio governance, and milestone management.</li>
</ul><b>Education</b>
<ul><li>Bachelor&rsquo;s degree in information technology, Cybersecurity, Business, or a related discipline.</li>
</ul><b>Certifications (Preferred)</b>
<ul><li>CISA (Certified Information Systems Auditor)</li>
<li>CRISC (Certified in Risk and Information Systems Control)</li>
<li>CISSP (Certified Information Systems Security Professional)</li>
<li>PMP (Project Management Professional)</li>
</ul><b>Delivery Methodologies</b>
<ul><li>Strong understanding of the Software Development Life Cycle (SDLC).</li>
<li>Experience applying compliance controls in both Agile and Waterfall delivery models.</li>
</ul><b>Professional Skills &amp; Attributes</b>
<ul><li>Regulatory Expertise: Ability to interpret complex regulatory and control requirements and translate them into clear, actionable guidance for technical and project teams.</li>
<li>Analytical Rigor: Strong attention to detail, particularly in validating technical evidence and identifying compliance gaps or control weaknesses.</li>
<li>Consultative Mindset: Ability to function as a trusted advisor while maintaining independence and objectivity when providing recommendations to leadership.</li>
<li>Communication Skills: Strong written and verbal communication skills, with the ability to bridge technical delivery requirements and compliance expectations.</li>
GRC &amp; Project Tool Proficiency: Experience with GRC platforms (e.g., ServiceNow, Archer) and project management tools (e.g., Jira), in addition to Planisware, to maintain visibility across projects and compliance activities.<li>-</li></ul></div></div></div></div></p>

Compliance Project Specialist

Novant Health

<div>What We Offer:
<div><b>
Clinical Practice Specialist</b></div><ul><li><b>
Schedule:</b> Monday through Friday 8-5pm</li><li><b>
Location:</b> Remote position</li><li><b>
Department:</b> Center for Professional Practice and Development</li></ul><div></div><div><br>
The Clinical Practice Specialist develops and directs a standardized clinical education curriculum and evidenced-based nursing care standards for an identified patient population. The Clinical Practice Specialist will support Adult Acute Care Departments.</div><div></div><div><br>
Travel Required to all regions of Novant Health.</div>
What We're Looking For:
<ul><li><b>Education:</b> Doctorate in Nursing Practice (DNP), required. Doctorate in Nursing Practice (DNP) or PhD or enrolled in a DNP or PhD program with completion within 1 year.</li><li><b>
Experience:</b> Minimum of three years clinical practice in specialty area, required. Critical Care or Adult Acute Care expereince, preferred.</li><li><b>
Licensure/certification/registration:</b> Current RN licensure in appropriate state, required. RN professional certification in relevant specialty, required.</li><li><b>
Additional Skills required:</b> Current and future trends/practice in area of responsibility; regulatory and governing standards, policies and procedures; information systems and software used in area of responsibility; equipment used in performing assigned duties; application of safety and infection control policies and procedures; teambuilding, conflict management, and interpersonal relationship skills; principles of adult learning and teaching methods/models; decision making, project leadership and consultation, delegation and communication skills; understanding of customer needs and expectations and knowledge for improvement to exceed customer expectations; knowledge of research and EBP methodologies and analyses; ability to write effectively.</li></ul></div>

Clinical Practice Specialist

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3538 regulatory specialist jobs Near Me

Clinical Research Regulatory Specialist

Clinical Research Regulatory Specialist

Regulatory Affairs Specialist

Clinical Trials Redaction/Regulatory Response Specialist

Part Time Lecturer, Regulatory Landscape of Cell & Gene Therapies

Compliance Project Specialist

Clinical Practice Specialist