Director of Regulatory Affairs - Confidential : Job Details

Director of Regulatory Affairs

About the Company

Join a highly respected biopharmaceutical company at the forefront of developing innovative cancer treatments.

Industry Biotechnology

Type Public Company

About the Role

We are actively seeking a passionate and experienced Director of Regulatory Affairs to spearhead and implement strategic and operational regulatory initiatives for our diverse portfolio, which encompasses assets from pre-clinical to clinical stages. In this pivotal role, you will formulate and oversee our regulatory strategy, maintain effective communication with regulatory authorities, and lead the Regulatory Affairs department.

We are looking for an individual with a robust work ethic, an entrepreneurial spirit, and a substantial background in regulatory affairs within the life sciences, especially in Hemato-oncology/Oncology and FDA-related requirements. Ideal candidates will possess a postgraduate qualification in a relevant field, preferably a PhD, research-based MSc, PharmD, or MD, along with at least 10 years of industry experience.

Your responsibilities will include:

• Overseeing all regulatory submissions and ensuring compliance.
• Preparing for and participating in meetings with US regulators.
• Providing executive leadership in the development of proactive regulatory strategies.
• Collaborating closely with cross-functional teams to support business development efforts.

The ideal candidate will have extensive hands-on experience with the FDA, particularly with CBER and OTAT, and a deep understanding of the regulatory landscape for cell and gene medicinal products. We seek a strategic, dynamic, and collaborative leader with exceptional communication, negotiation, and problem-solving skills. You will play a crucial role in shaping the company's vision and ensuring that the department meets corporate goals while aligning with relevant policies and regulations.

Hiring Manager Title Chief Regulatory Officer

Travel Percent Less than 10%

Functions

• General Management
• Operations
• Strategy