Regulatory Submission Project Planning Associate I

Basking Ridge, New Jersey
Nov 05, 2021
Required Education
Bachelors Degree
Position Type
Full time

Responsible for assisting with the project management of Regulatory submission deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). Requires guidance from direct manager. Provides support and backup to management as needed.

In this role, a typical day might include the following:

  • Assists with creating and maintaining Submission Plans (Table of Contents, Timelines, and responsibility matrix)
  • Coordinates submission documents (routing documents for review and uploading into the EDMS)
  • Assists with conducting kickoff, submission core team, and line function meetings Provides some guidance on good documentation and submission practices Assists with facilitating the resolution of timeline issues
  • Provides requested submission documents to partners and CROs Assists with maintaining and tracking regulatory commitments
  • Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance
  • Assists with preparing and submitting CAS and USAN applications Assists with regulatory inspection activities
  • Identifies and communicates regulatory system enhancement needs or technical issues to management and CDRA Systems Team

This role might be for you if:

  • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
  • Requires eCTD knowledge. Project management skills desired."
  • Can generally work independently (routine guidance from direct manager anticipated), ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
  • Working knowledge with MS Office applications and Adobe Acrobat is required. Working knowledge with MS Project and electronic document management systems (eg, SharePoint) is desirable.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.