Sr. Regulatory Affairs Director (Two Positions Available) – 40% work from home

Published: November 8, 2018
Various locations, United States
Job Type
Job Code
Years of Experience
Bachelor’s Degree
Ilia Cordero
Contact Email


  • Responsible for leading the CMC regulatory function, the SR/Director, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s).
  • Working collaboratively with our clients and senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing of regulatory CMC submissions and manage the interactions with all Health Authorities for CMC topics.
  • This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
  • Responsible for aiding in the coordination, authorship, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submission and marketing applications to FDA and international regulatory authorities), which support clinical programs, CMC and quality.
  • Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
  • Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.


  • BS in Science or Engineering degree with 10+ years pharmaceutical industry experience and a minimum of 8 years in Regulatory Affairs.
  • Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and commercial products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.
  • Key to success: must be able work independently and as some of job may assigned and conducted from home offices.
  • Must be hard worker abs ability to be flexible based on client needs.
Drop files here browse files ...

Related Jobs

Gear Engineer   Arizona, United States new
November 13, 2018
Senior Accountant   PR, Puerto Rico new
November 12, 2018
OPEX Manager   North Region, Puerto Rico new
November 12, 2018
Operations Analyst   PR, Puerto Rico
November 9, 2018
Operations Analyst   PR, Puerto Rico
November 9, 2018
Are you sure you want to delete this file?