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  5. Sr. Associate Regulatory Operations
  • ID
    #12268895
  • Job type
    Permanent
  • Salary
    TBD
  • Source
    Apex Systems
  • Date
    2021-04-14
  • Deadline
    2021-06-13

Sr. Associate Regulatory Operations

 Massachusetts, Boston, 02108 Boston USA
 
Permanent

Vacancy expired!

Sr. Associate, Regulatory Operations and Publishing 1131309 Job Scope & Purpose: Our Boston area clinical-stage biotech client is in search of a highly organized and efficient Regulatory Operations professional ready to join their team. This is a newly created role, and an opportunity to partner with the Head of Regulatory Operation, and a dynamic Regulatory Affairs team, working cross-functionally across the organization in preparation for their Global commercial launch. This a fantastic career growth opportunity for a Regulatory professional who is a creative, resourceful, and integrative thinker looking to be part of a hands-on and entrepreneurial culture. Primary Job Responsibilities:

  • Independently prepare and submit eCTD and non-eCTD submissions of varying complexity to IND/CTA and NDA/MAA applications
  • Format MS Word and Adobe Acrobat files to a state of submission-readiness
  • Act as department liaison to publishing and archival vendors
  • Provide support to Regulatory Affairs in the creation of submissions documents
  • Manage and maintain correspondence and other records in regulatory tracking system
  • Coordinate the exchange of records using document-sharing platforms
  • 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 process improvements
Primary Job Requirements:
  • Bachelor's degree or equivalent experience
  • 3 to 5 years of relevant Regulatory Operations experience in biotech/pharmaceutical industry
  • Strong understanding of submission requirements
  • Records management concepts, and electronic tools and systems.
  • Expert-level document formatting and submission building (eCTD and non-eCTD)
  • Expert-level knowledge of PDF Publishing tool (ToolBox preferred)
  • Proficiency in Microsoft Word, Microsoft Excel,
  • Acrobat Professional, and Sharepoint
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Excellent organization, written/verbal communication, and attention to detail
Preferred Experience:
  • Grouped and OPDP Submission experience
  • ToolBox
  • Acuta PDF
  • Extedo eCTDManager
  • Veeva Vault
  • Veeva RIMS
About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Code: RegQA #LI-SS1

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

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