Head of CMC Regulatory Affairs

Location
Newark, CA
Posted
Jul 17, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options. Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.


Summary
Our Head of Regulatory Affairs Chemistry, Manufacturing, and Controls will oversee and direct all CMC regulatory activities. They will provide strategic direction, conduct risk assessments, and oversee the preparation of all CMC regulatory agency documents and submissions. This will entail effective collaboration within the greater CMC team and cross-functionally with members of quality regulatory, manufacturing, etc. to ensure the integrity of CMC regulatory documents related to Rain-32, for patients with well-differentiated liposarcoma, Tarloxotinib, and other oncology therapeutics portfolio products.


Critical Performance Objectives:

  • Develop and execute regulatory plans in the preparation of CMC regulatory documents and submissions including NDAs, MAAs, INDs, etc) and ensure these documents meet high-quality standards and regulatory requirements
  • Own the internal document writing, review, and approval process for CMC related submissions and regulatory questions
  • Review CMC protocols and test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites Interact with manufacturing and quality groups, regulatory agencies, contractor, and partner organizations, regarding Rain portfolio product CMC issues
  • Facilitate internal RACMC stakeholder team meetings, providing strategic, scientific, and regulatory subject matter and maintain record keeping tracking and project management systems 
  • Resolve complex project issues related to regulatory requirements by interpreting, communicating, and working with other Rain team members to ensure agency approvals are obtained
  • Support processes by which regulatory submissions are reviewed, finalized, and approved
  • Ensure compliance with regulatory practices and procedures and work practices proactively identifying and resolving to mitigate risks
  • Support regulatory authority inspections (GBT) as required


Required and Preferred Education and Experience:

  • BA/BS in a science or health-related field; required MA/MS or Ph.D. preferred
  • 7+ yrs RACMC experience in the CRO, pharmaceutical, biotechnology, or device/diagnostics industry required; 10 yrs preferred
  • Previous small molecule and/or oncology therapeutic drug development experience strongly preferred 
  • Advanced knowledge of regulatory requirements, including ICH and FDA, required
  • Significant RACMC regulatory document preparation and submission experience required
  • Strong writing, time, and project management skills with exceptional attention to detail required
  • Strong leadership and cross-functional collaboration orientation preferred
  • Previous experience working in a startup or other fast-paced, dynamic environment strongly preferred


Qualities for Success:

  • Must have excellent written and oral communication skills
  • High energy, self-starter with the ability to work in a team environment, as well as independently
  • Strong time management and planning skills
  • Experience and passion to work with small teams and in a startup environment, able to work comfortably under pressure, frequently changing landscape and tight deadlines
  • Team builder, excellent in hiring team members and establishing expectations and results
  • Detail-minded yet flexible work style; manage multiple projects and timelines at one time, and rapidly change priorities based on business needs


Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.