Regulatory Affairs Director

JOB FUNCTION: Scientific
JOB TYPE: Direct Hire
LOCATION: Kenilworth , NJ
COMPENSATION: $165k - $195k
REMOTE / ONSITE: Remote
POSTED: Jan 13, 2023

Our client is a global pharmaceutical company with multiple therapeutic areas and they are seeking a Regulatory Affairs Director to join their team!

Salary/Hourly Rate:

$165,000 – $195,000

Position Overview:

The Regulatory Affairs Director will be responsible for creating and delivering strategic regulatory guidance for assigned projects or products. Strategies should align with global and regional positions, commercial goals, and key stakeholders. The Regulatory Affairs Director will develop and implement regulatory strategies for assigned projects or products.

Responsibilities of the Regulatory Affairs Director:

  • Assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects
  • Manage regulatory aspects of projects or products, including the preparation and submission of correspondence and applications to regulatory agencies and organizing and leading meetings with regulatory agencies, as appropriate
  • Develop Global and Regional regulatory strategies and implementation plans for complex projects or products

Qualifications for the Regulatory Affairs Director:

  • 5 to 10 years of Regulatory Affairs Strategy in a pharmaceutical environment
  • Experience working with  Country Regulatory Managers, Brand Teams, and Supply teams
  • Experience with briefing documents, Global Regulatory Strategy Documents, annual reports, IND, NDA, and/or MAA

Education Requirements:

  • Bachelor’s degree in business or a field related to a regulated industry (such as life sciences or finance) is required

Benefits:

  • Client provided benefits, upon eligibility
As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
EOE/M/F/D/V/SO
Position ID: 117661