Senior Manager, Regulatory

Purpose:Lead the Regulatory department to support all assigned individuals within the team.  This individual will provide oversight and will work proactively with the Care Access team to solve. The Sr. Manager, Regulatory oversees the Regulatory team members and supports all aspects of regulatory efforts for the Care Access site model and is responsible for helping ensure compliance with regulations. This individual will stay abreast of regulations impacting the business according to Care Access SOPs, GCP, FDA/ICH, country-specific and all other applicable Regulatory Guidelines.
 DUTIES INCLUDE BUT ARE NOT LIMITED TO:·         Be responsible for the development, implementation, and maintenance of robust North American regulatory strategies.·         Bring innovative regulatory approaches, to lead the team in discussions with Health Authorities across North America  to find the best developmental strategies.·         Lead and oversee all aspects of the regulatory team operations.·         Develop, improve, and make more robust the systems, repeatable processes, and workflows that support the successful function of the Regulatory team. ·         Lead a team of regulatory professionals, providing guidance, support and training as needed.·         Collaborate with cross-functional teams to ensure regulatory compliance and alignment with organizational goals.·         Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.·         Manage the successful onboarding and training of new hires to the Regulatory team.·         Drive continuous improvement initiatives in regulatory processes and systems to enhance efficiency and quality.·         Manage team and understand resource and capacity·         Identify and escalate risks up line as needed in a timely manner·         Implement project management strategies to best manage studies and deliverables ·         Build relationships with external partners to best support the Regulatory team and company.·         Provide back-up support to Regulatory Specialist role as needed including plan, prepare, and review submissions to applicable IRBs, such as:o   Initial submissionso   Continuing Reviewso   Study Closeout Reports●Manage generic regulatory submissions including ICF, prescreening plans, and all marketing/recruitment materials requiring IRB approval●Design creative solutions to stay within regulatory guidelines while the company creates new ways to run clinical trials.●Assist in the development and maintenance of KPIs to measure department success●Develop and maintain electronic regulatory platforms at Care Access.●Manage regulatory document/ISF quality through internal review (department QC) ·         Maintain knowledge of pertinent regulations and guidance ·         Manage study caseload & ISF●   Ensure quality is maintained in all investigator site files and regulatory workflows overall; Develop processes to verify compliance and best practice.●  Support the submission of new CLIA waiver applications and maintain CLIA certification for sites or other required Site or PI level regulatory registrations certificates as needed.●   Constantly strive to improve the department.●   Lead by example and display a high level of integrity and professionalism.Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive KNOWLEDGE, SKILLS, AND ABILITIES:●  Excellent working knowledge of medical and research terminology·           Expert knowledge of federal research regulations and good clinical practices (GCP)7+ years of experience in regulatory affairs within the clinical research industry, with specific experience working with IRBs and electronic Investigator Site Files (preferably experience in a Site Management Organization)Strong knowledge of US and Canadian regulations governing clinical trials and IRB processes.·         Demonstrated leadership skills with experience managing a team in a fast-paced environment.·         Excellent communication, organizational, and problem-solving skills. Ability to work independently, prioritize tasks effectively, and meet deadlines consistently.●   Ability to communicate and work effectively with a diverse team of professionals·         Ability to prioritize and handle multiple projects simultaneously.●   Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments●   Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.●       Strong computer skills with demonstrated abilities using CTMS and clinical trials database systems, electronic data capture, MS word, and excel.●       Ability to balance t