Regulatory Affairs Manager (Clinical Focus) at Axogen

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race color creed religion ancestry age sex marital status national origin disability or veteran status.Why youll love working atAxogen:Friendly openandfunteam culturethat values uniqueperspectivesCompany-wide dedicationto profoundly impacting patients livesComprehensive high-quality benefitspackage effective on date of hireEducationalassistanceavailable for all employeesMatching 401(k)retirementplanPaid holidaysincluding floating holidaysto be used at your discretionEmployee Stock Purchase PlanReferral incentive programAxogen Mission and Business PurposeOur business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions we will guide and expect the market and design requirement specifications underlying our engineering business development and clinical research activities objectively target advancements in standards of care.Job Summary of the Regulatory Affairs Manager (Clinical Focus)Reporting to the Sr. Manager Regulatory Affairs the manager will provide direction and leadership in the development and implementation of domestic and international regulatory strategies and processes for Axogens clinical programs in compliance with applicable regulations recommended guidance and standards. The manager will provide support to regulatory submissions regulatory activities cross-functional teams and supervise the preparation of regulatory deliverables to support clinical programs in domestic and international markets. The manager is accountable for cross-functional alignment relating to clinical regulatory strategy and deliverables. The manager will review information related to safety for Axogens product portfolio and perform corresponding regulatory assessments. The manager will perform clinical-focused regulatory intelligence activities related to the markets in which clinical programs are being considered or are in effect. The manager will be responsible for the management of Regulatory Specialist(s) and Interns. The manager will assist in or direct interactions with regulatory bodies and participate in regulatory inspections.Requirements of the Regulatory Affairs Manager (Clinical Focus)Bachelors degree required; in a scientific regulatory or health-related discipline preferredMinimum 4 years of experience in Regulatory Affairs with at least 1 year focused on clinical programs.Demonstrated leadership experience (cross-functional team leadership).Experience in regulatory writing and submitting successful regulatory submissions in both domestic and international marketsPrior experience in a regulated biologic combination product or device environment strongly preferred.Strong project management and strategic problem-solving skills; ability to manage multiple priorities in a fast-paced environment.Comprehensive knowledge relating to 21 CFRCurrent Good Clinical Practices (cGCPs) and ICH efficacy and safety guidelines.Ability to travel approximately 20%Responsibilities of the Regulatory Affairs Manager (Clinical Focus)The specific duties of the Regulatory Affairs Manager (Clinical Focus) include but are not limited to:Acts as the Regulatory-Clinical representative on cross-functional clinical development teams to ensure regulatory requirements recommended guidance and applicable standards are incorporated into the development process and continued compliance is maintained.Provides regulatory oversight for assigned projects focused on clinical development programs and the regulatory maintenance of active trials.Participates in clinical risk-benefit analysis providing input and a regulatory perspective regarding risk assessment.Keeps Senior Management informed of the regulatory status of products clinical programs and significant regulatory issues and provides updates regarding new developments.Leads and drives submission activities (planning authoring reviewing coordination compilation submission) for assigned projects in both investigational and post-marketing lifecycle phases.Coordinates with Regulatory Operations on the submission management of clinical amendments and supplements to applications inclusive of providing guidance on correct eCTD locations and document lifecycle phases for submission content.Creates and manages Clinical Study records in Vault RIM.Coordinates with Clinical Sciences and Operations Medical Affairs and Pharmacovigilance representatives on the creation and maintenance of documentation maintained within investigational applications e.g. clinical efficacy and safety sections investigators brochure protocols and risk-related documentation.Coordinates with Clinical representatives on processes and regulatory requirements for maintaining public records of clinical trials (such as ).Assesses information related to safety in coordination with Axogens Pharmacovigilance group for reportability requirements across applicable markets.Maintain and improve practices standard operating procedures (SOPs) metrics work instructions reports and forms keeping with current regulatory requirements and best practices.Provide department support during FDA (BIMO) and other external or internal auditsProvide continuing regulatory education and dissemination of regulatory information to the clinical development and pharmacovigilance groups as well as other groups as necessary.Location13631 Progress Blvd. Alachua FL 32615OR111 West Oak Ave. Tampa FL 33602#LI-AC1Benefits/CompensationThis position is eligible for an annual bonus.Benefits offered for this position include Health Dental Vision Matching 401K Paid Time Off 9 Paid Holidays 3 Floating Holidays Dependent Care Flexible Spending Accounts Medical Flexible Spending Accounts Tuition Reimbursement Paid Parental Leave Paid Caregiver Leave Basic Life Insurance Supplemental Life Insurance Employee Stock Purchase Plan and Disability Insurance as described in more detail in summary plan descriptions.Salary Range$110585$138231 USDAxogen follows healthcare system guidelines with respect to credentialing vaccinations and other employment/compliance related requirements as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.Required Experience:Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full Time Experience: years Vacancy: 1