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Director, Regulatory Affairs

Company: Stratacuity: Proven Scientific Placement
Location: Bethesda
Posted on: April 3, 2021

Job Description:

Our esteemed client offers all phases of development and pending approval in sight for their small molecule treatments for acute organ injury. They seek a talented Director, Global Regulatory Strategy and Development to join an extremely talented, growing clinical team to support their robust pipeline. This individual is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development of the company's drug products. Primary Job Responsibilities:

  • Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.--
  • Functions as the global regulatory lead for assigned projects, working with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC and Operations at a minimum.
  • Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects.
  • Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
  • May serve as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
  • Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
  • Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
  • May supervise Regulatory Affairs Associates. Primary Job Requirements:
    • BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
    • Has a minimum of 10 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical industry in other areas. 3-5 plus years of management experience preferred.
    • Experience in IND phase Regulatory strategy development and implementation
    • Experience developing global regulatory strategies for products in development across therapeutic areas and in various phases of development, especially IND phase.
    • Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
    • Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
    • Experienced in responding to inquiries from HAs.
    • Represents the organizational unit as key internal and external contact for GRA
    • Strong interaction with leadership in global regulatory affairs and development functions and senior business unit leadership.
    • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
    • Excellent interpersonal, communication, analytical, managerial, and organizational skills. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
      PROVEN SCIENTIFIC PLACEMENT--- Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178. Apex Systems dba Stratacuity, is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Keywords: Stratacuity: Proven Scientific Placement, Bethesda , Director, Regulatory Affairs, Executive , Bethesda, Maryland

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