Program Manager, Regulatory Affairs

SUMMARY OF POSITION

The Program Manager, Regulatory Affairs is responsible for planning and timely submission of regulatory filings for new and existing marketing authorizations. 

ORGANIZATION STRUCTURE

This position will report directly into the Vice President, Regulatory Affairs and is based in Morristown, New Jersey.  

RESPONSIBILITIES

  • Develop regulatory submission plans and execute regulatory submissions for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
  • Plans, conducts submission team meetings and reviews project progress with team a regular basis
  • Must be able to set and communicate timelines for the regulatory submissions including delivery of supporting documentation from functional groups
  • Must work with all functional areas to obtain needed information on time
  • Must be able to work with authors to ensure documents for Health Authority MAA/NDAs dossier content including labeling, meetings requests, briefing packages, PAS, CBE 30s, Annual Reports are submission ready   
  • May participate on internal project teams to update business processes.
  • Anticipates the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed 
  • Represent or lead the RA function on assigned cross-functional project teams
  • Monitor applicable regulatory requirements; assure compliance with Almatica  and external standards
  • Establish appropriate communication within RA organization and other functions primarily at project level
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong oral and written communication and presentation skills 
  • Demonstrated interpersonal skills including strong negotiation skills

QUALIFICATIONS

  • Minimum of Bachelor's Degree in relevant field. A masters degree or higher and/or a focus in the pharmaceutical/life sciences is preferred
  • Scientific Background 
  • Minimum of 5 years regulatory experience in Regulatory Affairs or related field
  • Previous experience in project management is beneficial 

 

We are an EEO Employer.