Principal Regulatory Affairs Consultant at Syner-G BioPharma Group

RemoteFull-timeRemoteRegulatoryPosted 9 days ago

About the Role

<div class="content-intro">COMPANY DESCRIPTION:  A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video <a href="https://www.youtube.com/watch?v=2rUMvtncuw8">here</a>.  Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.  At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.  For more information, visit <a id="menur1aj1" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="https://www.synergbiopharma.com/" target="_blank">www.Synergbiopharma.com</a></div> <div>POSITION OVERVIEW: </div> <div>As a Senior General Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. You will serve as a strategic partner, leveraging your expertise to navigate regulatory requirements and optimize pathways for drug submissions. </div> <div> WORK LOCATION: Travel to client sites may be required based on project demands and client expectations. KEY RESPONSIBILITIES: </div> <ul> <li>Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients. </li> <li>Handle FDA Type A, Type B, and Type C meetings.</li> <li>Engage in all phases of drug development, from early-stage to post-registration. </li> <li>Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams. </li> <li>Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality. </li> <li>Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines. </li> <li>Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements. </li> <li>Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement. </li> <li>Serve as the main point of contact for clients, ensuring effective communication and regulatory support. </li> <li>Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes. </li> <li>Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions. </li> <li>Partner with clients on Non-Clinical/Clinical strategy and submissions. </li> <li>Evaluate proposed manufacturing and quality changes for impact on existing registrations. </li> <li>Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities. </li> </ul> <div> </div> <div>QUALIFICATIONS AND REQUIREMENTS:</div> <div> </div> <div>Education:</div> <ul> <li>Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred.</li> <li>RAC Certification is a significant advantage; equivalent certifications or extensive experience in regulatory affairs are highly valued. </li> </ul> POSITION OVERVIEW: The Validation Project Manager / Business Analyst is responsible for leading validation system implementation activities for digital validation platforms such as ValGenesis or within a regulated pharmaceutical environment. This role serves as both a project manager and a validation business analyst, bridging business, quality, and technical stakeholders to ensure successful deployment, configuration, and adoption of electronic validation lifecycle management systems. The ideal candidate has hands-on experience implementing ValGenesis for Life Sciences organizations, strong understanding of validation and compliance workflows, and the ability to drive structured requirements, system configuration, testing, and end-user readiness.  WORK LOCATION: Travel to client sites may be required based on project demands and client expectations. KEY RESPONSIBILITIES: <ul> <li>Lead end-to-end project management activities related to the implementation of ValGenesis, Kneat, or similar electronic validation lifecycle management platforms.</li> <li>Conduct detailed analysis of client validation processes to document user requirements, functional specifications, system requirements, and workflow needs.</li> <li>Plan and facilitate stakeholder workshops, discovery sessions, and Conference Room Pilots (CRPs) to assess current-state validation processes and define future-state solutions.</li> <li>Configure ValGenesis or Kneat software to meet client-specific requirements including workflows, templates, user roles, and validation objects.</li> <li>Develop business requirements, configuration documents, user stories, and related documentation needed to support system implementation.</li> <li>Partner with Quality, Validation, IT, Engineering, and Manufacturing stakeholders to ensure alignment on system functionality, compliance requirements, and operational needs.</li> <li>Develop and support testing activities including unit testing, functional testing, regression testing, and user acceptance testing (UAT).</li> <li>Troubleshoot system issues, track resolutions, and coordinate with technical teams to ensure timely remediation.</li> <li>Prepare training materials and lead end-user training sessions to support system adoption and change management.</li> <li>Support go-live readiness activities including cutover planning, migration validation, and hypercare support.</li> <li>Ensure implemented solutions align with GxP expectations, validation best practices, and regulatory standards.</li> <li>Provide ongoing support, guidance, and continuous improvement recommendations for validation system usage.</li> <li>Contribute to best practices, process standards, and knowledge sharing across the project team.</li> </ul> QUALIFICATIONS AND REQUIREMENTS: Education: <ul> <li>Bachelor’s degree in Computer Science, Life Sciences, Engineering, Industrial Engineering, Pharmaceutical Technology, or related field. Equivalent experience considered.</li> </ul> Experience: <ul> <li>7–12 years of experience as a Business Analyst, Project Manager, or Validation SME supporting system implementation within the pharmaceutical or Life Sciences industry.</li> <li>Direct experience implementing Kneat or ValGenesis in a GxP environment is required.</li> <li>Experience working with validation, quality, compliance, or regulated manufacturing processes.</li> <li>Experience supporting cross-functional technical and validation workstreams on medium- to large-scale programs.</li> <li>Experience with CSV, GAMP 5, validation documentation, and electronic validation systems.</li> </ul> Knowledge, Skills, and Abilities: <ul> <li>Strong background in drug development, biologics, and clinical trials. </li> <li>Proven experience in handling INDs, NDAs, BLAs, and global submissions. </li> <li>Demonstrated ability to adapt to client needs, providing strategic advice and tactical support across various therapeutic areas. </li> <li>Attended relevant conferences, training, and job shadowing opportunities. </li> <li>Proficient in Microsoft Office Suite and industry-specific software tools such as Trackwise, Veeva, and ICTD. </li> <li>Strong understanding of drug development, manufacturing, and clinical development processes. </li> <li>Experience in authoring and managing Non-Clinical/Clinical Medical Device and FDA sections for regulatory submissions. </li> <li>Ability to evaluate manufacturing and quality changes for regulatory impact. </li> <li>Demonstrated proficiency in regulatory information management systems and tools. </li> </ul> ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here represent the requirements for successful performance of the essential functions. Reasonable accommodations may be made for individuals with disabilities. While performing job duties, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The role requires frequent walking and sitting, and occasional lifting of objects up to 25 pounds. Vision requirements include close vision and the ability to adjust focus. Work Environment: The work environment characteristics include a typical office environment with moderate noise levels, bright lighting, and an indoor temperate setting. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture. This includes a competitive base salary, annual incentive plan, comprehensive benefits, and ongoing recognition and career development opportunities. Employees benefit from flexible paid time off, company-paid holidays, flexible working hours, and remote work options for most roles. Office locations are available in Greater Boston; San Diego, CA; Boulder, CO; and India. Syner-G is unable to sponsor or take over sponsorship of employment visas at this time.  LEGAL STATEMENT:   Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

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