Regulatory Associate

Remote – Full Time Position

Position Overview

As a Regulatory Associate at Accorto, you will be a key contributor to our organization, responsible for preparing, reviewing, and editing regulatory documents for FDA submissions. The Regulatory Associate will work closely with cross-functional teams to gather and compile technical information and ensure that all regulatory documents meet FDA guidelines and regulations.

Key Responsibilities:

  • Research and determine the optimal regulatory pathway for clients’ products, and collaborate with the commercial team to convey these to clients in an understandable and compelling manner.

  • Collaborate with cross-functional teams, including regulatory affairs professionals, scientists, engineers, project managers, and subject matter experts to gather technical data and information for regulatory submissions.

  • With support, author, review, and edit regulatory documents such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), Premarket Approval Applications (PMA), 510(k) submissions, Investigational Device Exemptions (IDE), Pre-sub/Q-Sub Requests, Premarket Tobacco Product Applications (PMTAs), and other FDA regulatory submissions and related documents.

  • Ensure the accuracy, completeness, and compliance of regulatory documents with FDA requirements, guidelines, and current regulations.

  • Perform thorough reviews of clinical trial data, technical reports, manufacturing processes, and scientific literature to ensure the relevance, accuracy, and validity of information in regulatory submissions; apply critical thinking to such data to detect unexplained anomalies and intellectual curiosity to explore explanations.

  • Ability to read, interpret, and apply FDA guidances, stay current with evolving FDA regulations and industry standards, and incorporate these changes into regulatory documents as needed.

  • Manage the submission process to FDA, including document tracking, electronic submission (eCTD), formal and informal FDA communications, and coordination of responses to regulatory inquiries.

  • Maintain organized and comprehensive documentation of all regulatory writing activities, ensuring version control and document management.

  • Collaborate closely with regulatory affairs colleagues and project managers to meet submission deadlines and support clients in achieving regulatory milestones.

Qualifications

  • Bachelor’s degree in a scientific or technical discipline; advanced degree (MSc or Ph.D.) is a plus. Additional post-graduate studies in regulatory science.
  • All necessary skills to quickly prepare regulatory reports and submissions.
  • Strong scientific background with 3+ years of experience in regulatory writing, with a focus on FDA submissions in the medical, pharmaceutical, or nicotine product spaces.
  • In-depth knowledge of FDA regulations, guidance documents, and submission requirements. European IVDR knowledge is a plus.
  • Demonstrated ability to work with/for the FDA.
  • Excellent written and verbal communication skills, with the ability to convey technical information clearly and concisely.
  • Strong attention to detail and the ability to critically review and assess technical data, and use data to make a compelling case related to product safety and efficacy when appropriate.
  • Proficiency in Microsoft Office Suite, electronic document management systems, and eCTD software.
  • Project management and organizational skills to manage multiple submissions and deadlines.
  • Ability to work collaboratively in a team environment and adapt to changing priorities.
  • Ability to quickly adapt to new regulations, guidelines, and industry trends.
  • The ability to think strategically about regulatory pathways and submission strategies can be a major asset. This includes foreseeing potential regulatory hurdles and planning accordingly to mitigate risks.
  • The ability to critically evaluate data, regulatory guidance, and literature, and to apply this information to solve complex regulatory challenges.
  • Familiarity with regulatory requirements beyond the FDA, such as EMA (European Medicines Agency) or Health Canada, can be beneficial for companies with a global presence or aspirations.
  • A commitment to ongoing learning and professional growth, including the pursuit of relevant certifications or memberships in professional regulatory affairs organizations.
  • Tolerance for adapting to changing priorities which comes with working within an advisory firm environment.

Interested in Joining our Team?

Apply today!


Apply via Linkedin or submit your resume to:

[email protected]

Accorto Regulatory Solutions is committed to creating a diverse environment and is proud to be an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.