northdakota | Director of Regulatory Affairs in Fargo, ND

Director of Regulatory Affairs

  • Aldevron
  • $106,000.00 - 164,810.00 / Year *
  • 2600 Southgate Dr S
  • Fargo, ND 58103
  • Full-Time
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We are a rapidly growing company that manufactures biologics to help accelerate scientific research and breakthroughs. We are seeking a Director of Regulatory Affairs to lead the regulatory function to support the company's strategic plan, future growth, and increasing expectations of regulatory authorities and customers. This position will develop the vision and strategy for Regulatory Affairs and set the standard for the overall regulatory environment at Aldevron. Qualified candidates will have:* BA/BS in science related field.* Prefer Regulatory Affairs certification or MA/MS in Regulatory Affairs.* 10+ years of relevant regulatory affairs experience, US and EU primary focus for drug or biologic products.* In-depth familiarity with a variety of drug regulatory affairs concepts, practices and procedures.* Extensive experience and demonstrated ability to plan, track and accomplish goals, encompassing a wide variety of tasks and working with different multidisciplinary team members.* Regulatory submission experience, specifically experience with CMC, DMFs, and eCTD content and format submissions for INDs and/or NDAs.* Strong knowledge of Health Authority regulations and industry standards. About the Role* Develop regulatory strategies for current Aldevron services in collaboration with other senior level management personnel.* Act as primary liaison for communications with FDA and other regulatory authorities associated with the clinical and commercial services (e.g. DMF, risk assessments, CMC, support of client eCTD submissions for INDs and NDAs).* Lead and/or participant in development and execution of regulatory strategy to support projects.* Develop positive and proactive approaches to regulatory compliance to ensure client satisfaction, providing counsel to and managing the regulatory team.* Work with the sales, marketing, and product management function to ensure Aldevron's products and services are accurately positioned with regards to regulatory compliance.* Provide guidance to multi-disciplinary teams on the regulatory requirements for proposed and current development projects.* Oversee regulatory submission activities. Review regulatory reports and documentation to ensure regulatory compliance (such as those from quality, preclinical and clinical disciplines) for submission in INDs, NDAs and other applications.* Lead or participate in agency meetings; oversees development of agency meeting requests and briefing documents* Monitor impact of changing regulations on submission requirements and updates internal stakeholders.* Represents regulatory affairs on various committees.* Creates and manages budgets, manages resourcing for current and future projects* Lead or assist with other projects and activities as assigned by management in support of the regulatory affairs function.* Play a lead role in the development of high throughput parallel manufacturing and quality systems to address the neo-antigen space.* In coordination with QA, support and liaise with Health Authority regulatory officials during site inspections and manage responses required to address inspection activities.* Understand and interpret US/EU Regulations (and other countries as needed), guidance documents, and guidelines; provide guidance on regulatory requirements to senior management, quality assurance etc.* Identify and communicate potential risks and mitigations associated with regulatory strategies to senior management* May lead training of functional areas and assist in the development of site GMP regulation training sessions in partnership with Quality. Why Join Aldevron?* You want meaningful work. We are in a landmark moment in the history of life science, and Aldevron is at the center of it.* You want to plant your career in a growing company. We are growing fast. We have limitless opportunities for people who are ready to roll up their sleeves and jump in.* You are excited to learn every day. At Aldevron, no day is the same. Our team comes to work ready to learn and overcome new challenges with teamwork and a passion to make lives better. Your talents, ideas, and passion are essential to our success. Join us today! Associated topics: analyst, facebook, major gift, market, mba, policies, presale, product market, public, solicitation
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.