Director, Regulatory Affairs & Product Development - Nonclinical (Remote)

Cardinal Health Regulatory Sciences (CHRS) is a consultancy organization that specializes in regulatory affairs related to drug, device, and biologic product development in the pharmaceutical industry. For 45 years, our industry-trained CMC, nonclinical, clinical, and regulatory consultants have provided expertise and guidance that has enabled pharmaceutical, biotechnology, and medical device companies achieve marketing approval of products. Our mission is in part to design and execute regulatory and product development strategies that reduce the risk of failure and increase financial returns on research investments by pharmaceutical companies worldwide. We provide effective scientific and regulatory consulting services throughout the full product lifecycle.  We are growing and looking for talented regulatory affairs experts to help increase our global presence and lead our clients in achieving product development and marketing approval milestones.

The Director (Principal Scientist), Regulatory Affairs Nonclinical will support multiple pharmaceutical companies as a Regulatory Affairs Leader and Subject Matter Expert in Nonclinical Development. Key contributions of this role include developing and implementing regulatory strategies, overseeing all aspects of programs and projects, and lead Health Authority meetings and interactions for our clients, among others.

Regulatory Affairs & Product Dev with an Emphasis on Nonclinical Consulting -- Responsible for nonclinical development and regulatory affairs consulting to provide innovative solutions and regulatory submissions for all aspects of pharmaceutical, biologics, advanced therapy products, and device development from discovery through post-approval maintenance.

  • Manage a wide variety of projects involving most aspects of the drug development process involving nonclinical and regulatory affairs, including strategic development, evaluation of scientific information, and preparation and maintenance of scientific and regulatory documents.
  • Establish nonclinical development plans, gap analyses, scientific and regulatory strategies, project outlines and timelines, as well as develop and implement nonclinical and regulatory strategies for addressing a wide variety of project needs.
  • Provide regulatory guidance and assistance to clients in a timely manner regarding scientific and regulatory problems, issues, concerns, questions, and strategies associated with the drug development process. Use experience to develop strategies to streamline development and approval process.
  • Interacts with regulatory authorities, including providing liaison responsibilities, preparation for, and attendance at meetings and teleconferences.
  • Prepare and maintain scientific and regulatory documents, including but not limited to IND, NDA, BLA, MAA, PMA/510k, Annual Reports, Amendments, Supplements, Investigator’s Brochures, ODDR, etc.
  • Understand and support the nature of our business and our company’s commitment to quality and responsiveness. Work with business development to prepare customer specific proposals. Manage budgets with primary focus on scientific deliverables.
  • Encourage informed risk taking and acts as a catalyst for innovation; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.
  • Proactively develop and maintain broad knowledge of the technical disciplines in own functional area(s); apply broad knowledge of trends and best practices in a manner that ensures exceptional performance and results.
  • Communicates with clients and health authorities with a sense of urgency, in a timely and clearly manner.
  • Manage and direct project teams, including identifying, directing, and delegating tasks necessary for successful regulatory project completion.
  • Direct, assist, and train other staff regarding scientific and regulatory drug development.
  • Demonstrates strong teamwork with internal resources, SMEs to capitalize on intellectual property. Collaborates well with internal and external stakeholders in achieving project goals.
  • Flexible to understand and handle multiple and varied projects, which may not fall within this job description.

Nonclinical Drug Development Focus

  • Recognized industry expert to provide guidance in the areas of toxicology, regulatory, pharmacokinetics/ADME, and pharmacology for small molecules, biologics, and advanced therapy biotherapeutics.
  • Substantial experience (minimum of 10 years) evaluating and summarizing nonclinical data (pharmacology, pharmacokinetics, toxicology) verbally and in writing
  • Substantial experience (minimum of 10 years) writing nonclinical regulatory submission documents including pharmacology, pharmacokinetics, and toxicology data.
  • Develop and implement strategies for assessment of compounds being developed by the animal rule.
  • Complex issue resolutions as it relates to data interpretation.
  • Preparation of responses to regulatory agency questions/response documents.
  • Negotiate with regulatory authorities regarding nonclinical data and strategies.
  • Demonstrated experience in the preclinical development of biotherapeutics and safety issue resolution
  • Strong cross-functional communication skills to effectively communicate information and concerns across functions

Qualifications

  • Bachelors and Advanced degree in relevant field preferred
  • 12+ Years of experience in Nonclinical Regulatory Affairs
  • Technical expertise in Toxicology
  • Experience in a consulting environment supporting sponsors and clients in the pharmaceutical, biotech, and/or medical device industry
  • Experience communicating and interacting directly with major health authorities
  • Regulatory affairs experience in advanced or gene therapies preferred
  • Experience working in a matrixed, global, and multi-site environment
  • Strong written and verbal, analytical, organizational, and interpersonal skills
  • Ability to manage multiple ongoing projects, each at various stages of development, with minimal if any supervision
  • Demonstrated ability to influence stakeholders effectively and positively
  • Strong attention to detail and right-the-first-time approach
  • Interest and/or experience leading a team
  • This is a remote work from home position
  • A Covid-19 vaccination is required in order to be employed in this position. This includes either:
    • 2 doses of the Moderna or Pfizer vaccine
    • 1 dose of the Johnson & Johnson vaccine

Anticipated salary range: $175,000-$215,000

Bonus eligible: Yes

Long term incentive eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.