Director, Regulatory Affairs

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Deliver strategic and operational regulatory consulting services for client organizations.

• Provide strategic advice to clients, emphasizing early development stages through NDA/BLA.

• Independently create regulatory documentation, including US IND, NDA/BLA modules, ODD, Fast Track and other designations, as well as FDA advice requests.

• Collaborate scientifically with internal cross-functional teams.

• Act as a point of contact for clients and regulatory agencies.

• Engage with clients and the FDA, leading discussions with Health Authorities.

• Assist in internal business development and marketing initiatives.

⛳️ Requirements

• Bachelor's degree in science, toxicology, pharmacology, engineering, or a related discipline.

• An advanced scientific degree such as a Master's, Ph.D., or Pharm.D. is preferred, with relevant applied training in clinical trials.

• 10 years of pertinent experience working directly for a CRO or pharmaceutical company.

• At least 5 years of experience in leading regulatory development projects.

• Comprehensive understanding of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other relevant regulatory rules and guidelines.

• Familiarity with medical terminology, clinical trials, and clinical research.

• Exceptional written and verbal communication abilities, including strong grammatical and technical writing skills.

• Knowledge of moderately complex study designs and regulatory requirements for Phase I-IV clinical trials.

• Thorough understanding of the relationship and regulatory obligations between the contract research organization (CRO) industry and pharmaceutical/biotech companies.

• Proven technical and supervisory leadership of personnel.

• Proficient in Microsoft Word and Microsoft Excel, with the capacity to learn new applications.

• Outstanding interpersonal, communication, and organizational abilities.

• Capability to work independently as well as collaboratively in a team setting.

🏝️ Benefits

• Remote working opportunities.

• Flexible time off policies.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement programs.

• Retirement plans.

• Eligible for bonuses.