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Head of Regulatory Affairs

2 months ago

Waltham, United States Muraloncology Full time

Description:

We are looking for a dynamic Head of Regulatory Affairs whose responsibilities include regulatory oversight and strategic development of our products throughout the product lifecycle. This individual will lead Regulatory Strategy, Regulatory Operations, and Regulatory CMC. Success in this role requires strong leadership skills, exceptional working knowledge of global regulatory procedures and a proven track record in leading global submissions and approvals of BLAs/MAAs for oncology products. As such, the individual should possess a strong capability for entrepreneurial strategic thinking, collaboration, and flexibility with respect to developing non-traditional regulatory paths consistent with health authority guidelines and regulations.

Responsibilities:

  1. Establish a vision in line with the long-term direction of the business and communicate to all levels of the organization.
  2. Develop and grow the Regulatory Affairs department in keeping with the needs of the company; coach and mentor department staff.
  3. Develop an organization that brings expert science, creativity, and innovation; knowledge and regard of regulations; respect for teamwork and others; and a commitment to the success of the business.
  4. Support the overall business needs through continuous process improvement, relationship building, critical staffing, personnel growth, and career development.
  5. Collaborate with research and development, marketing, and operations to develop regulatory strategies that will creatively position innovative oncology products for expeditious health authority review/approval.
  6. Provide senior management with critical risk assessments and strategic alternatives for regulatory submissions and health authority engagement strategies.
  7. Establish regulatory capabilities that will ensure the effectiveness of due diligence assessments/decision-making to support business development activities.

Job Requirements:

  1. Advanced degree, Ph.D. Pharm D. or M.D. in science field such as Biology, Chemistry, or Pharmaceutical sciences is preferred.
  2. 15 years of Pharmaceutical/Biotech experience, with at least 7 years’ Regulatory Affairs experience in biologic drug development and registration activities.
  3. Senior-level management of assets over the full regulatory life cycle.
  4. Proven strategic development capabilities related to new drug development and commercial support activities.
  5. Strong oncology drug development knowledge and experience.
  6. An extensive background and excellent relationship in working with the FDA and other regulatory agencies; broad experience in global drug development.
  7. Superior leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies.
  8. Good oral and written communications, time management, and team-oriented leadership skills are essential.
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