Reports to

Executive Vice President, Regulatory Affairs

Summary/Objective

This position is responsible for supporting all regulatory projects in conjunction with other regulatory and clinical professionals

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Prepare regulatory submissions, e.g., FDA IND supplements and international clinical trial applications (CTA).
  • Coordinate submission components, perform final preparation, assembly, formatting, editing, proofreading, and quality control of regulatory documents intended for investigational drugs or new drug applications.
  • Prepare new investigator information, routine protocol amendments, and other information amendment submissions to US FDA and work with International contract groups to ensure submission to foreign agencies.
  • Coordinate input into clinicaltrials.gov in conjunction with clinical department to ensure information is accurate and properly reviewed prior to release
  • Search and retrieve submissions from regulatory archives
  • Coordinate department projects, meetings, and conferences both internal and external with other departments, regulatory agencies, partners, and consultants.
  • Oversee completion of general department activities.

 

Competencies

Detail Oriented, Organizational Skills, Strong Verbal and Written Communication skills, Interpersonal Skills, Problem Solving

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role; however, some filing is required; it would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position. The typical workweek is five eight-hour days, Monday through Friday. Occasional evening and weekend work may be required as job duties demand.

Travel

No travel is expected for this position.

Required Education and Experience

  1. Typically requires a Bachelor’s degree with 2 to 4 years of related experience. Without degree, additional related experience is required.

Additional Eligibility Qualifications

  1. At least 2 years of experience in the preparation of regulatory documents for IND or NDA submission, including editing, proofreading, layout, document preparation and filing to regulatory agencies.
  2. At least 4 years of relevant experience in the pharmaceutical industry highly desirable
  3. Advanced use of Microsoft Word and other Microsoft Office products, Adobe Acrobat, and database programs.
  4. Experience with eCTD publishing software desirable.
  5. Familiarity with regulatory practices, principles, and ICH eCTD submission structure.
  6. Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.

AAP/EEO Statement

Equal Employment Opportunity Employer

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.