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

Published: November 8, 2018
Location
Various locations, United States
Job Type
Category
Job Code
22886
Years of Experience
8
Travel
Yes
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

Description

  • 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.

Requirements

  • 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.
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