R37171 Director, Pharma Regulatory Services

At LexisNexis Reed Tech, we believe that when people and organizations are enabled with technologies and services that help them achieve regulatory compliance, manage product data, and gain insights backed by analytics, the potential to positively impact patient outcomes is unlimited.

Today, we are a market leader in helping more than 1,200 global pharmaceutical companies submit updated labeling information in Structured Product Labeling (SPL) format to the FDA to maintain regulatory compliance.  We also help biologics manufacturers submit Lot Distribution Reports to the FDA. 

On a daily basis, we get asked by our customers whether we can perform additional regulatory services, and our goal is to expand our services capabilities to support additional needs related to new drug applications using eCTD, medical writing, US agent services etc.

Role Overview

We are looking for an entrepreneurial, seasoned leader with deep regulatory services domain expertise who can help us identify and scale service expansion opportunities so we can more holistically address customer needs directly. Reporting into the General Manager, Life Sciences, you will be responsible for initially defining a service expansion strategy and then executing against that expansion strategy to build and scale the team and manage ongoing profit and loss.

Responsibilities:

• Develop and update a pharma regulatory service expansion strategy aligned with customer needs with clear articulation of areas to focus, and a plan to scale
• Recruit, train, develop, coach and manage service expansion team
• Establish tools, processes and work instructions to perform tasks to generate high quality deliverables
• Provide subject matter expertise in customer conversations and/or conversations with regulators
• Supervise the quality of the deliverables produced by the services team, and assure results meet high customer and Reed Tech quality and turnaround standards
• Manage on-going profit and loss for service expansion efforts
• Provide sales and marketing guidance on how to articulate value proposition of new services as well as assist in thought leadership
• Maintain working knowledge of changing global regulatory requirements to advise teams on regulations, guidelines, procedures, and policies relating to development and registration of new pharma products
• Willingness and ability to travel (domestically and internationally) as required ~10%.

Key qualifications:

• Master's degree in life sciences or related disciplines with 8 years or more of relevant experience in global Regulatory Affairs in the pharmaceutical/biotech industry, supporting both development projects and marketed products
• Experience of leading regulatory affairs services team in a consulting environment for 3 or more years
• Has deep regulatory expertise in pharmaceuticals
• Has developed and executed global regulatory strategies for investigational drugs/biologics
• Has deep understanding of and experience in regulatory affairs processes, including:
  • Electronic drug registration and listing
  • US agent and import regulations
  • eCTD packaging for regulatory submissions to the FDA for NDA, ANDA and other drug applications
  • Corresponding with regulatory authorities
  • Medical writing
• Strategic and analytical thinker and problem solver
• Excellent written and oral communication skills, including regulatory writing, are essential
• Solid working knowledge of the drug development process and FDA, EU, ICH and other regional regulations and guidelines
• Team leader who demonstrates emotional intelligence, initiative, ability to effectively lead cross-functional team and influence team members as needed to achieve results within agreed timelines
• RAPS certification desired
• Successfully team leadership experience in regulatory affairs department at a small to mid-sized pharmaceutical company a plus
• Experience with medical device regulations a plus.