Senior Regulatory Affairs Strategist

Senior Regulatory Affairs Strategist

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships, and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Senior Regulatory Affairs Specialist is responsible for driving investigational product lifecycle development across multiple projects, therapeutic areas, interventions, and study phases. This position will collaborate with both internal and external stakeholders to provide support in preparing documentation for submission to regulatory agencies worldwide.

Responsibilities
  • Develops client- and product-specific regulatory strategies for lifecycle management of new drugs, biologics, advanced therapeutics, and devices through pre-submission, clinical trial, and licensure processes
  • Directly prepares and reviews documentation in support of pre-submission meetings (pre-IND, INTERACT, Q-Submission), IND/CTA submissions, and marketing applications (NDA, BLA, 510k, PMA, etc.)
  • Reviews early-phase client documentation (e.g. manufacturing procedures, non-pivotal animal study protocols and data, clinical synopses) and performs gap analysis activities, and facilitates generation of lifecycle resources such as Target Product Profiles and Clinical Development Plans
  • Participates in development and review of IND/CTA application materials including clinical protocols, informed consent documents, investigational plans, Investigator Brochures, nonclinical and clinical data summaries, and manufacturing information
  • Performs maintenance of IND/CTA applications, including but not limited to generation of annual reports/development safety update reports, information amendments, protocol amendments, and safety reports
  • Provides advice on timing and documentation required for product lifecycle designations (e.g. Orphan Drug, Fast Track, Breakthrough Therapy) and other milestone activities (e.g. End-of-Phase meeting), and performs supportive authoring and review activities as needed
  • Provides ad hoc consultative support to clients as necessary
  • Performs program management activities, including establishment of timelines and logistical processes for the drafting, review and submission of required information from key internal and external stakeholders, allowing sufficient time to compile information and prepare reports
  • Works closely within the Regulatory Affairs Department (inclusive of Regulatory Strategy, Regulatory Operations, and Medical Writing teams) and with project teams to develop, review and maintain regulatory document templates
  • Utilizes regulatory subject matter expertise to mentor teammates and other internal stakeholders, as applicable
  • Tracks regulatory activities and communicates status to project team and external stakeholders
  • Provides guidance and generates applicable documentation to capture transfer of Sponsor regulatory obligations to Emmes
  • Reviews and contributes to project-required reports, as necessary (e.g., quarterly activity reports)
  • Participates in regular Regulatory Affairs Department and project team meetings, providing input on regulatory issues regarding clinical trial conduct and the status of regulatory filings
  • Maintains a current understanding of ICH guidelines and US FDA regulations and guidance
  • Communicates and coordinates effectively with internal and external clients and colleagues
  • Provides recommendations for process improvements
  • Produces work products and maintains documentation in compliance with corporate and project SOPs


Experience
  • Bachelor's degree in a scientific discipline (Master of Science or PhD preferred)
  • Possess at least 5 years of experience at the Regulatory Specialist/Scientist level or higher
  • Possess a working knowledge and understanding of applicable FDA regulations (Health Canada and EU Competent Authority regulations a plus)
  • Possess multidisciplinary understanding of regulatory affairs (e.g. clinical, non-clinical, manufacturing disciplines), with a strong understanding of CMC preferred
  • Direct experience in drafting, reviewing, and maintaining applications in the Common Technical Document format with the FDA
  • Experience in evaluating product manufacturing information, GMP compliance documents and scientific/technical data and reports preferred
  • Experience with cell and gene therapies preferred
  • Experience with biosimilar development a plus
  • Experience with quality control review of regulatory documentation preferred
  • Experience with generation of prospective client proposals and budgets a plus
  • Regulatory Affairs Certification (RAC) or equivalent preferred
  • Have strong skills in MS Word, Excel, and Outlook (document collaboration systems a plus, e.g. SharePoint, Box for Business)
  • Experience working both on HHS-funded and Industry-funded clinical studies is a plus


Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
  • Unlimited Approved Leave
  • Tuition Reimbursement
  • 401k & Profit-Sharing Plan
  • Work From Home Anywhere in the US
  • Maternal/Paternal Leave
  • Casual Dress Code/Work Environment


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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