Mural Oncology
Head of Regulatory Affairs
Mural Oncology, Waltham, Massachusetts, United States, 02254
Mural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to address areas of unmet need for patients with a variety of cancers. The Company's lead product candidate, nemvaleukin alfa, is an investigational, engineered interleukin-2 (IL-2) cytokine designed to capture and expand the therapeutic benefits of high-dose recombinant human IL-2, while mitigating its hallmark toxicities.
Job Description
Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
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:
• Establish a vision in line with the long-term direction of the business and communicate to all level of the organization.
• Develop and grow the Regulatory Affairs department in keeping with the needs of the company; coach and mentor department staff.
• 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.
• Support the overall business needs through continuous process improvement, relationship building, critical staffing, personnel growth, and career development.
• 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.
• Provide senior management with critical risk assessments and strategic alternatives for regulatory submissions and health authority engagement strategies.
• Establish regulatory capabilities that will ensure the effectiveness of due diligence assessments/decision-making to support business development activities.
Job Requirements:
• Advanced degree, Ph.D. Pharm D. or M.D. in science field such as Biology, Chemistry, or Pharmaceutical sciences is preferred.
• 15 years of Pharmaceutical/Biotech experience, with at least 7 years' Regulatory Affairs experience in biologic drug development and registration activities
• Senior-level management of assets over the full regulatory life cycle.
• Candidates must have proven strategic development capabilities related to new drug development and commercial support activities.
• Strong oncology drug development knowledge and experience.
• An extensive background and excellent relationship in working with the FDA and other regulatory agencies; broad experience in global drug development.
• Must have superior leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies.
• Good oral and written communications, time management, and team-oriented leadership skills are essential.
Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
Job Description
Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
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:
• Establish a vision in line with the long-term direction of the business and communicate to all level of the organization.
• Develop and grow the Regulatory Affairs department in keeping with the needs of the company; coach and mentor department staff.
• 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.
• Support the overall business needs through continuous process improvement, relationship building, critical staffing, personnel growth, and career development.
• 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.
• Provide senior management with critical risk assessments and strategic alternatives for regulatory submissions and health authority engagement strategies.
• Establish regulatory capabilities that will ensure the effectiveness of due diligence assessments/decision-making to support business development activities.
Job Requirements:
• Advanced degree, Ph.D. Pharm D. or M.D. in science field such as Biology, Chemistry, or Pharmaceutical sciences is preferred.
• 15 years of Pharmaceutical/Biotech experience, with at least 7 years' Regulatory Affairs experience in biologic drug development and registration activities
• Senior-level management of assets over the full regulatory life cycle.
• Candidates must have proven strategic development capabilities related to new drug development and commercial support activities.
• Strong oncology drug development knowledge and experience.
• An extensive background and excellent relationship in working with the FDA and other regulatory agencies; broad experience in global drug development.
• Must have superior leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies.
• Good oral and written communications, time management, and team-oriented leadership skills are essential.
Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.