Director of Regulatory Operations - Oncology Biotech (Fully Remote)
We are seeking a highly experienced and motivated individual to join our dynamic team as the Director of Regulatory Operations at our oncology-focused biotech company. As a key player in our regulatory affairs department, you will be responsible for overseeing and driving regulatory operational strategies to ensure compliance with global regulatory requirements. This is a fully remote position, allowing you to contribute to our mission from the comfort of your own home.
Regulatory Operations Leadership:
- Provide strategic leadership and direction for the regulatory operations function, ensuring alignment with organizational goals.
- Manage and mentor a team of regulatory professionals, fostering a collaborative and results-driven culture.
- Oversee the planning, execution, and delivery of regulatory submissions globally.
Global Regulatory Compliance:
- Stay abreast of global regulatory guidelines and requirements, particularly in the field of oncology.
- Develop and implement regulatory operational strategies to ensure compliance with international regulations and standards.
- Lead the planning, coordination, and preparation of regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), and Marketing Authorization Application (MAA).
- Ensure timely and high-quality submission of documents to health authorities, collaborating with cross-functional teams.
- Possess expert knowledge of electronic Common Technical Document (eCTD) format and submission processes.
- Implement best practices for eCTD submissions, ensuring accuracy and completeness.
- Identify opportunities for process improvements within regulatory operations to enhance efficiency and effectiveness.
- Implement systems and tools to streamline regulatory processes, fostering continuous improvement.
- Collaborate closely with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to integrate regulatory strategies into overall project plans.
- Act as a liaison between regulatory affairs and other departments to ensure alignment and communication.
- Minimum of 5 years of experience in regulatory operations within the biotech/pharmaceutical industry
- Proven experience in leading regulatory operations teams.
- In-depth knowledge of global regulatory requirements, particularly in the oncology therapeutic area.
- Strong understanding of eCTD submission processes and tools.
- Excellent leadership, communication, and interpersonal skills.
- Ability to thrive in a fully remote work environment.
- Bachelor's degree in a scientific or related field required; advanced degree (MS, PhD, or MBA) preferred.
Location: Fully Remote
If you are a strategic thinker with a passion for oncology and regulatory affairs, and you thrive in a remote work setting, we invite you to apply for this exciting opportunity to contribute to the advancement of innovative oncology therapies. Join us in our mission to make a meaningful impact on patients' lives.