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Director Oncology Regulatory Affairs

Reference Number: 3205
Location: MA

Our client is a rapidly growing, specialty biopharmaceutical company.  They have asked us to assist them in their search for Director Oncology Regulatory Affairs.

Major tasks and responsibilities will include:

  • Develops and implements effective regulatory strategies for the development and commercialization of the company’s portfolio.
  • Ensures adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements.
  • Together with corporate senior management, completes a deep dive assessment of the corporate regulatory strategy and formulate a playbook incorporating company milestones, contingency plans, and risk.  This playbook will complement business objectives, partnering strategies (other pharma/biotech and service providers), internal and external systems, and R&D/commercial timelines.
  • Cultivates and solidifies relationships with key stakeholders.
  • Develops content and formatting for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments.
  • Advises and oversees internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes.
  • Oversees preparation, submission, application, and routine reports including preparation of amendments and supplements as required by internal departments.
  • Sustains excellent relationships with regulatory agency personnel including responses to requests for additional data and participation in meetings.
  • Negotiates directly with regulatory authorities regarding company’s filings.
  • Brings together an over-arching regulatory strategy encompassing CMC, regulatory operations, labeling, and DDMAC activities.
  • Develops, implements, and reviews current policies and practices issued by Federal and international regulatory agencies.
  • Provides regulatory support for due-diligence activities.
  • Helps to develop and update SOP strategy across functions.
  • Participates in leadership activities to enhance company culture and rapid growth.  Foster an innovative environment with the purpose of advancing the company’s’ interests and furthering the company’s mission to bring needed therapies to cancer patients.
  • Ensures highest caliber of internal staff through hiring, mentorship, and appropriate oversight, and an effective network of outside partners, collaborators, and service organizations.

We seek candidates with the following qualifications:

  • MS, PhD, PharmD, MD or JD is preferred.
  • Required 7-15+ years related experience within the biotechnology/pharmaceutical industry, as well as 7+ years of clinical regulatory experience.
  • Oncology experience required; Phase I-II experience is preferred.
  • This person must have experience in filing INDs, NDAs/BLAS, and MAA application.
  • This person must have knowledge of eCTD submissions and supportive technologies.
  • Impressive track record of delivering outstanding results, including the successful filing and launching of multiple products globally is a must.
  • This person must have a patient centric mindset. 
  • Large and small company work experience in a fast-paced, entrepreneurial environment is preferred.
  • Successful track record of presenting to corporate officers and board members.
  • Strong influencing skills.
  • Critical thinking capabilities.
  • Superior management skills and business acumen.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3205. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.