Regulatory Affairs Associate

Location
Gaithersburg, MD
Posted
Apr 27, 2022
Ref
2022-1755
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

Adaptive Phage Therapeutics (APT) is a clinical-stage biotech advancing therapies to treat multi-drug resistant infections. We are on a mission to address today's — and tomorrow's — toughest infections. We are looking for intelligent and motivated people to help us reach those goals.

Exciting opportunity for a Regulatory Affairs Associate to join the team at Adaptive Phage Therapeutics, Inc. (APT) to help support our innovative regulatory strategy in developing bacteriophage to treat antibiotic resistance infections. In this hands-on role, the successful candidate will work collaboratively with cross-functional team members to support development milestones in an efficient and compliant manner by helping with the preparation, managing, and filing of regulatory submissions to the FDA and other international Health Authorities. Besides supporting all aspects and goals of the Regulatory Affairs department, the successful candidate will be exposed to and participate in other company-wide initiatives.

Responsibilities

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

  • Work closely with regulatory management and cross-functional team members to support the preparation, submission, and review of regulatory documentation (including submission and maintenance of INDs, BLAs, meeting information packages, etc.)
  • Liaise with electronic submission contractor to manage submission preparation processes and assure accurate, complete, compliant, and timely electronic regulatory submissions.
  • Provides support for APT's emergency use and expanded access programs
  • Maintain status of regulatory submission tracking tools.
  • Archive regulatory submissions according to departmental procedures and processes.
  • Support due diligence activities.
  • Liaise with functional areas and/or CROs to obtain needed documentation for routine regulatory submissions.
  • Review of routine CMC changes.
  • Contribute to continuous improvements that have a positive impact on the working of the Regulatory Affairs function in connection with other departments.
  • With mentoring and guidance from Regulatory Affairs management, work to develop and acquire regulatory skills and knowledge following detailed instruction with well-defined procedures
  • Other duties as needed.

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

Qualifications

  • Bachelor of Science degree from an accredited college or university.
  • Basic knowledge/understanding of regulatory environment (ICH, different regulatory mechanisms and authorities, eCTD, GCP, GLP and GMP)
  • At least 3 years of experience in the biologic pharmaceutical industry preferred.
  • Excellent verbal and written communication skills and interpersonal skills.
  • Strong information seeking skills and ability to work independently.
  • Excellent organization skills and ability to work on multiple projects with tight timelines.
  • Attention to detail with accuracy and quality.
  • Full COVID-19 vaccination required; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job and will be available to the candidate upon request.

 

***APT is an Equal Opportunity/Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

 

 

Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through the Adaptive Phage Therapeutics Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Adaptive Phage Therapeutics, and no fee/payment will be paid. Recruiters interested in working with Adaptive Phage Therapeutics can submit their information to hr@aphage.com and we will contact you if needed.