Senior Manager/Associate Director, Global Regulatory Affairs

OncoBay Clinical is a full service CRO focusing on complex oncology indications including Immunotherapy and cellular therapies. We know that innovative research requires innovative operations and build that into our culture, systems and processes.  Our culture values and rewards critical thinking and open dialogue about quality — and that goes far beyond sole reliance on tools and checklists. We have an infrastructure to enhance access to patients, and integrated technology to provide higher quality and faster access to results. We remain vigilant and consistent with the advice in FDA Guidance on Monitoring, which encourages a quality risk management approach to clinical trial design and operation, and discourages a one size fits all mentality.

Are you ready to think outside the box and drive results? OncoBay Clinical might be the next right step to build your career and to make a difference.

SUMMARY OF POSITION

 

The Senior Manager/AD of Global Regulatory Affairs (GRA) is responsible for the preparation, coordination, and management of simple and complex regulatory submissions. The Senior Manager will work independently and within group settings to act as a liaison between GRA and other functional areas, including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to health authorities.  The Senior Manager will be responsible for initial submission and management of clinical trial applications (EU/ROW) and will ensure compliance and maintenance of existing IND applications.  The Senior Manager will coordinate the development of initial INDs and marketing applications and will ensure compliance and maintenance of approved applications as required.

 

The Senior Manager must  maintain good working knowledge of US FDA regulations, ICH guidance’s, clinical trial requirements, and Common Technical Document format.

 

ROLES AND RESPONSIBILITIES

 

The Senior Manager, Global Regulatory Affairs is responsible for the following:

 

  • Actively contribute to the development and implementation of regulatory strategy for assigned projects.
  • Prepare, coordinate, manage or maintain simple and complex regulatory submissions related to INDs and Clinical Trial Applications (CTAs), including initial applications, amendments, safety reports, DSURs/annual reports, meeting packages, and special pathway submissions in accordance with applicable regulations.
    • Coordinate internal and external authoring, review, comment adjudication and finalization of submissions as applicable, including coordination with submission management/publishing and archival of final documentation.
    • Provide review and comment during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content.
    • Responsible for the day-to-day management of regulatory aspects of clinical development programs, including development of core documents and review and approval of CTA submissions.
    • Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
    • Identify and resolve regulatory issues by coordinating and obtaining input from Subject Matter Experts (SMEs) as needed.
    • Interface with and provide guidance to external regulatory groups/vendors (e.g., CRO, partner, consultants, etc.) in the preparation, review, compilation, finalization, approval and submission regulatory applications.
  • In conjunction with Global Regulatory Lead, author, coordinate, manage or maintain simple and complex regulatory submissions related to US NDAs/BLAs including initial applications, post-filing submissions, and post-marketing maintenance submissions.  Including coordination of response requests, managing requirements and commitments, etc.
    • Coordinate internal and external authoring, review, comment adjudication and finalization of submissions as applicable, including coordination with submission management/publishing and archival of final documentation.
    • Identify and resolve regulatory issues by coordinating and obtaining input from Subject Matter Experts (SMEs) as needed.
  • Coordinate with Regulatory Project Management the development of reliable submission plans and timelines.
  • Support GRA activities with other functional areas as required including representing GRA in cross-functional team meetings.
  • Monitor company progress toward fulfillment of regulatory commitments.
  • Contribute to local process improvements and initiatives to improve overall efficiency, quality and/or output within GRA, including the authoring and review of standard operating procedures (SOPs).
  • Serve as a leader within GRA to help drive best practices.
  • Remain current on regulatory requirements (e.g., Domestic and International) that may impact the regulatory strategy and clinical operations related activities.
  • Translate and present pertinent evolving regulatory requirements to GRA and to internal/external functional business units as needed.

 

ORGANIZATIONAL STRUCTURE

Reports to Director, Global Regulatory Affairs

 

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

 

Educational Requirements

 

  • Bachelor’s or Master’s degree in a scientific discipline, regulatory affairs or equivalent. Regulatory Affairs Certification (RAC) is preferred.

 

Professional Work Experience

 

  • Candidate must possess at least 6+ years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
  • Experience working with innovative products, including gene therapy, biologics, and implementation of creative development strategies are highly desirable.
  • Must have a solid understanding of FDA regulations and ICH guidance’s, as well as a comprehension of the drug development process.
  • Experience with regulatory submission development, including EU Clinical Trial Application experience, along with experience with US INDs, international/rest of world clinical trial applications, and marketing applications is required.
  • Experience with US marketing applications (NDAs/BLAs) pre- and post-filing and marketing submission.
  • Knowledge of Common Technical Document format.
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks.
  • Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates.

 

 

 

 

Location: Remote - U.S.

Apply

Take Advantage of OncoBay’s Innovative Approach

CONTACT ONCOBAY CLINICAL