Director of Regulatory Affairs bei Evolution Research Group

About Company:

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders.  ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. 

Job Description:

The Director of Regulatory Affairs oversees regulatory strategies for submissions and manages document deliveries to assure submission targets are met. Review of Sponsor submissions, as well as internal documents to assure proper regulatory records are accurate and complete to meet the FDA and GCP/ICH guidelines.

Responsibilities:

• Liaison between ERG Regulatory Affairs and Sponsors’ Regulatory divisions.
• Oversight of eReg across the organization.
• General oversight of flow of Regulatory and IRB submissions, including meeting established submission deadlines to stay on track with company projections.
• Oversight of regulatory-related start-up activities at new facilities (hospital review, Reliance Agreements, pharmacy, and lab documentation, etc.).
• Collaborate with Site Directors/Managers on feasibilities.
• Collaborate with various ERG departments (Contracts, Recruitment, etc.) as needed for reg and IRB submission completion, facility approvals, physician onboarding and other related areas.
• Interface with IRBs as necessary
• Reviews regulatory and related documents to ensure compliance.
• Ensures on-time submissions and approvals of draft or amended protocols and/or Informed Consent Forms
• Collaborate with ERG and Site Leadership on Work Instruction development and implementation to maintain consistency across sites.
• Collaborate with Recruitment Dept to create company-wide prescreening programs.
• Provide sound regulatory advice/guidance to ERG Executive and Clinical Research staff.
• Negotiate and manage regulatory time commitments and resources.
• Manage COI disclosures as necessary.
• Mentor, develop, and train staff.
• Adhere to compliance and privacy/confidentiality requirements and standards.
• Has a working knowledge of GCP/ICH guidelines, internal SOPs, and individual protocols
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

Skills and Qualifications:

• A minimum of ten years of experience in clinical research Regulatory Affairs required.
• Regulatory Affairs Certification preferred but not required.
• Clinical research experience preferred but not required.
• Good working knowledge of medical terminology and the clinical research process
• Expert computer skills, including knowledge of all components of Microsoft Office are required.