Strategic Regulatory Affairs Director for Biotherapies

4 weeks ago


Scottsdale, Arizona, United States Vitalant Full time
Job Summary

Vitalant is seeking a highly skilled Sr. Director, Biotherapies Regulatory Affairs to lead our regulatory initiatives and ensure compliance with regulatory requirements. As a key member of our team, you will be responsible for developing and executing regional regulatory strategies to support the development, registration, and commercialization of advanced biotherapy products.

Key Responsibilities
  • Provide excellent leadership, communication, and interpersonal skills to influence and collaborate effectively with cross-functional teams.
  • Develop and execute regional regulatory strategies to support the development, registration, and commercialization of advanced biotherapy products.
  • Collaborate with cross-functional teams, including manufacturers, research & development, clinical, collections, and commercial functions, to ensure regulatory compliance and alignment of regulatory activities and development.
  • Oversee, prepare, and submit regulatory documents, applications, and licensures to regulatory agencies that govern biotherapies operations and compliance.
  • Foster relationships within industry and regional regulatory authorities, including the FDA, to facilitate communication, negotiations, and interactions related to policy, practice standardization, regulatory submission, and approvals.
  • Monitor regulatory development, changes, and identify trends while assessing impact on product development and provide strategic guidance to the executive management team.
  • Provide regulatory guidance and support for post-marketing activities, including variations, renewals, labeling updates, and compliance initiatives.
  • Serve as a subject matter expert on regulatory requirements, guidelines, best practices, and provide training, mentorship, and guidance to regulatory team members and cross-functional stakeholders.

Requirements
  • Bachelor's degree in a scientific discipline, such as life sciences, pharmacy, or biosciences.
  • Advanced degree preferred.
  • RAPS Regulatory Affairs Certification (RAC) Certification preferred.
  • Eight years of experience in regulatory affairs within the pharmaceutical or biotech industry.
  • Five years of leadership experience.
  • Strong knowledge of regulatory requirements and guidelines, including the FDA and ICH guidelines.

About Us
Vitalant is one of the nation's largest nonprofit blood and biotherapies healthcare organizations, providing hospitals and patients across the U.S. a safe blood supply, specialized laboratory services, transfusion medicine expertise, and world-renowned research.
  • Compliance Specialist

    4 weeks ago


    Scottsdale, Arizona, United States LoLo's CNW, LLC Full time

    Job DescriptionWe are seeking a highly skilled Compliance Specialist to join our team at LoLo's CNW, LLC. The ideal candidate will have a strong background in regulatory affairs and a proven track record of ensuring compliance with legal requirements and industry standards.Key ResponsibilitiesMonitor legislative changes and industry trends to ensure our...

  • Director of Finance

    4 weeks ago


    Scottsdale, Arizona, United States Crescent Services Full time

    Director of FinanceCrescent Hotels and Resorts is seeking an experienced Director of Finance to lead our financial operations. As a key member of our team, you will be responsible for providing strategic financial guidance, managing cash flow, and ensuring compliance with regulatory requirements.Key Responsibilities:Evaluate the financial impact of business...


  • Scottsdale, Arizona, United States Innovative Health LLC Full time

    Job SummaryThe Director of Quality Systems will lead the establishment and maintenance of a Quality System that meets FDA and ISO requirements, while ensuring customer satisfaction and positively impacting the company's financial performance.Key Responsibilities:Develop and implement quality policies and procedures to ensure compliance with regulatory...


  • Scottsdale, Arizona, United States Innovative Health LLC Full time

    The Senior Director of Quality Management Systems at Innovative Health LLC is responsible for establishing a Quality System that meets FDA and ISO requirements, customer expectations, and drives business growth. This leader champions continuous improvement efforts to establish an effective Quality System, providing quality leadership to all levels of the...


  • Scottsdale, Arizona, United States Onsemi Full time

    At Onsemi, we are seeking an exceptional Strategic Technology Transfer Director to join our corporate technical transfer team. This is a critical role that requires a self-motivated individual to drive the successful transfer and production ramp of Onsemi technologies in front-end factories. The successful candidate will have a strong track record of project...


  • Scottsdale, Arizona, United States Innovative Health LLC Full time

    The Vice President of Quality Management Systems is a key leadership position at Innovative Health LLC, responsible for establishing and maintaining a Quality System that meets FDA and ISO requirements, customer expectations, and drives business growth. This role champions continuous improvement efforts to establish an effective Quality System, providing...

  • Nursing Director

    1 month ago


    Scottsdale, Arizona, United States Vi Living Full time

    Overview:Vi Living is a leader in providing exceptional care and services to seniors. We are seeking a highly skilled and experienced Nursing Director to join our team at Grayhawk. As a Nursing Director, you will be responsible for overseeing all aspects of care and services provided in the Care Center, including assisted living, memory support, and skilled...


  • Scottsdale, Arizona, United States Advisor Group Full time

    The Director of Third-Party Risk Management will lead the implementation, coordination, and administration of Advisor Group's TPRM program.This individual will collaborate with stakeholders in managing high-level risks arising from key third-party vendor relationships.The Director will set strategy for enhancing the overall program, develop oversight and...


  • Scottsdale, Arizona, United States GitKraken Full time

    Job DescriptionRole OverviewGitKraken is seeking a highly skilled FP&A Manager to lead the company's strategic, business, and financial planning processes. This role will be responsible for driving business performance management, financial and operational planning, and forecasting.Key ResponsibilitiesPartner with leadership to define, operationalize, and...


  • Scottsdale, Arizona, United States Aeronix Inc. Full time

    Job DescriptionJob Title: General Manager/DirectorSalary range: $155,000.00 to $175,000.00 + company performance bonusAs a key member of the Aeronix Technology Group, you will play a critical role in managing and overseeing Business Development and Program management associated with commercial and government contracts. You will be empowered to expand our...


  • Scottsdale, Arizona, United States Marriott International Full time

    Job SummaryThe Director of Finance and Accounting will serve as the property's strategic financial business leader, championing, developing, and implementing property-wide strategies to deliver products and services that meet or exceed the needs and expectations of the brand's target customer and property employees. This role will provide financial expertise...


  • Scottsdale, Arizona, United States Cogir Senior Living Full time

    Cogir Senior Living Job OpportunityJob Title: Director of Compensation and BenefitsJob Summary:The Director of Compensation and Benefits will develop, implement, and manage comprehensive compensation and benefits programs to support our company's strategic objectives and foster a positive employee experience. This role is essential to attracting, motivating,...


  • Scottsdale, Arizona, United States KBE Building Corp Full time

    Job DescriptionBusiness Development Director OpportunityKBE Building Corporation is seeking a highly skilled Business Development Director to join our team in Arizona. As a key member of our leadership team, you will be responsible for formulating and implementing the business development strategic plan for our Arizona office.Key Responsibilities:Develop and...

  • HR Director

    3 weeks ago


    Scottsdale, Arizona, United States Envita Medical Center Full time

    Job Title: Human Resources DirectorLocation: North Scottsdale, AZCompensation: Depending on ExperienceEmployment Type: Full Time with Benefits (Medical, Life, Dental, and Vision)Schedule: Monday through Friday 9 am to 5 pmJob Description: Envita Medical Center, a leader in integrative medicine, seeks an experienced HR Director to oversee all HR initiatives,...


  • Scottsdale, Arizona, United States Envita Medical Center Full time

    Job Title: Human Resources DirectorEnvita Medical Center, a leader in advanced integrative medicine, is seeking an experienced Human Resources Director to oversee all HR initiatives, systems, and operations. This role will be responsible for developing plans for various HR matters, including health and safety, benefits, compensation, employee engagement, and...


  • Scottsdale, Arizona, United States DAS Technology Full time

    Transformative Leadership Opportunity at DAS TechnologyAt DAS Technology, we are seeking a visionary Director of Human Resources to spearhead our People Operations function. As a key member of our leadership team, you will be responsible for driving strategic initiatives that foster a culture of innovation, collaboration, and growth.Key...


  • Scottsdale, Arizona, United States CNA National Warranty Career Full time

    Financial Operations DirectorAt CNA National Warranty Career, we are seeking a highly skilled Financial Operations Director to oversee all company accounting practices. This includes accounting, financial reporting, tax, SOX compliance, and audit functions. The ideal candidate will assess organizational performance against both the annual plan and the...

  • Marketing Director

    4 weeks ago


    Scottsdale, Arizona, United States Fort McDowell Yavapai Nation Full time

    Job Title: Marketing DirectorFort McDowell Yavapai Nation is seeking a highly skilled Marketing Director to lead the development and execution of strategic marketing plans for We-Ko-Pa Casino Resort. The ideal candidate will have a strong background in marketing, advertising, and brand management, with a proven track record of driving revenue growth and...


  • Scottsdale, Arizona, United States SmartRent Full time

    Job Title: Senior Director of Client SuccessSmartRent is seeking an experienced Senior Director of Client Success to lead the development and execution of multiple client programs, ensuring a seamless handoff from sales to post-sales, while aligning deliverables with our clients' business goals and objectives.Responsibilities:Own the Client Experience: Lead...


  • Scottsdale, Arizona, United States America's Rehab Campuses Full time

    Job Title: Corporate Director of Human ResourcesJoin America's Rehab Campuses as we seek a highly skilled and experienced Corporate Director of Human Resources to lead our HR team. This is a unique opportunity to make a meaningful impact on the company's success.Job Summary:The Corporate Director of Human Resources will be responsible for providing strategic...