Director, Regulatory Affairs

Job Locations US-IL-LAKE FOREST
ID
2021-1139
Category
Management
Type
Regular Full-Time

Overview

Responsible for ensuring Assertio’s regulatory compliance and serving as the internal expert advisor on regulatory requirements.  Establishes and executes the corporate regulatory strategy necessary to support clinical development programs (IND/IMPD), new registrations (NDA/MAA), commercialization activities, and post marketing improvements (PAS, CBE, etc.) in collaboration with internal and contracted cross functional stakeholders.  Serves as the key point of contact and support for regulatory agency interactions, queries, and inspections.  

Responsibilities

Essential Job Functions

  • In collaboration with the executive leadership, establishes the corporate regulatory strategy to support both development and commercial products to achieve company objectives.
  • Maintains an in-depth knowledge of regulatory requirements and guidance and functions as the “Regulatory Voice” for project teams in defining compliant pathways to successful regulatory submissions and updates. 
  • Works in collaboration fellow team members to develop content for regulatory submissions following eCTD format, in addition to annual reports and PADERs.
  • Facilitates the generation of new and revised product labeling and advertising/promotional materials in collaboration with key internal and external stakeholders
  • Review and management of Medical Affairs/PV/Clinical/Regulatory contracts – will streamline, manage and work with Legal to finalize contract approvals for all vendors, CRAs, consultants, etc.
  • Performs internal audits for regulatory compliance of investigator related studies, clinical trials, PV, complaint handling, and other fee for service consultant arrangements
  • Systems/SOP development and training for drug safety reporting, labeling, et. al.

Additional Responsibilities/Duties

  • Manage other regulatory employees/subordinates and external fee for service resources/consultants
  • Completion of assigned tasks with a high level of quality within departmental and company timelines.
  • Ability to learn on the go and obtain the skills needed to work within a technical environment.
  • Travel domestically and internationally may be required (10% or less)

Qualifications

Education/Experience

  • 10+ years’ experience in regulatory affairs in the pharma/biotech industry with first-hand involvement in preparing, maintaining, and managing INDs and NDAs.
  • BA/BS degree in a science discipline or equivalent experience in related field required. Advanced degree preferred.
  • In-depth knowledge of the drug development process and associated FDA/ICH regulations and guidelines for all phases of pharmaceutical/biotech development, commercialization, and post approval life cycle
  • Experience with timely preparation of pre-approval and post-marketing submissions, with a proven track record of approvals.
  • History of direct written and verbal interactions with FDA and other regulatory agencies
  • Previous experience with managing and supervising staff and external consultants

Physical Requirements

  • Ability to operate a motor vehicle
  • Ability to travel via airplane
  • Ability to sit for long periods of time
  • Ability to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal.
  • Reaching: Extending hand(s) and arm(s) in any direction.
  • Standing: Remaining upright on the feet.
  • Pushing: Using upper extremities to press against something with steady force in order to thrust
  • Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position of up to 20 lbs. on occasion

 Mental Requirements

  • Ability to prepare and analyze data and figures
  • Ability to understand, remember and apply oral and written instructions
  • Ability to organize and prioritize own works schedule
  • Ability to apply common sense in performing job
  • Ability to understand and follow instructions

Accommodations for Applicants with Disabilities

Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.

 

For more information about your EEO rights as an applicant under the law, please click here.

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