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Sr. Associate, Regulatory Operations

Cambridge, Massachusetts 02142

Post Date: 03/05/2018 Job ID: 1711 Job Category: Clinical: Regulatory

Our client is searching for a creative, resourceful, integrative thinker for a role responsible for all aspects of Regulatory Operations including submission project management. 

Job  Responsibilities:
  • Publication and submission of electronic submissions (and paper submissions, when required) to regulatory agencies to support the conduct of clinical trials and marketing authorizations, primarily for the U.S.
  • Create and maintain archives of communications with Health Authorities.
  • Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement associated process improvements.
  • Support regulatory documentation users and contributors.
  • Leads assigned projects with manageable risks and resource requirements
  • Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH regulations.
  • Acts as submissions representative on local and global project teams; provides resource and timeline estimates for regulatory submissions, as well as technical submissions expertise, as needed.
  • Develops and maintains best practices for the Submissions Group consistent with evolving FDA guidelines for electronic submissions.
  • Provides support to Regulatory Affairs and other project stakeholders in the creation of submissions documents.
  • Position has direct impact on the company' s ability to meet goals and timelines related to regulatory submissions. Identifies and escalates issues which may impact submission timelines and goals.
  • Assists the regulatory affairs liaisons in the determination of submission strategy.

Qualifications/  Requirements:

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, excellent analytical skills and an ability to communicate issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
  • BA/BS degree or equivalent experience
  • Experience in Regulatory Operations in a biotech/pharmaceutical industry is a plus, open to junior level candidates
  • Extensive experience with Microsoft Word, Adobe Acrobat, and electronic publishing software Experience with Starting Point templates preferred
  • Experience using electronic document management systems.
  • Thorough current knowledge of CTD/eCTD format and regulatory submission requirements
  • Experience compiling IND, NDA, and other CTD submissions
  • Experience in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally preferred
  • Strong attention to detail and the ability to manage multiple tasks
  • Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.

Denise Kowalski
Clinical Recruiter

Denise is a focused, relationship-driven individual who brings creative energy and an eagerness to conquer new challenges to her role. A passionate life-long learner, Denise’s excellent communication skills, strong work ethic, and genuine interest in helping others make her a valuable asset to the Clinical team.

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