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Regulatory Affairs Senior Associate

Newbury Park, CA
Description:
Note:

REMOTE - no time zone preference
What are the hours/schedule the contractor will be expected to work?
Monday-Friday 8-5 PM, with the ability to support Pacific Time zone based on business needs in the evenings.

Ideal Candidate:
  • Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA.
  • Degree in life sciences is also the preferred academic background.
  • Good communication skills - both oral and written.
  • Ability to understand and communicate scientific/clinical information, Organizational skills.
  • Knowledge of clinical regulatory submissions including IND, sIND, BLA, and sBLA useful. Use of document archival systems/electronic document repositories also useful.
  • Coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Management and execution of the preparation, delivery and electronic archiving of documentation for inclusion in regulatory submissions.
  • Coordination and execution of regulatory affairs processes and deliverables.
  • Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory documents.

Technical: 
  • Proficiency in Microsoft Suite (Outlook, Word, Excel, PowerPoint) Technical competency for data entry into electronic document management systems, SharePoint sites and other databases/trackers.

Preferred Skills:
  • Strong communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Ability to resolve conflicts and develop a course of action
  • Cultural awareness and sensitivity to achieve global results
  • Planning and organizing abilities
  • Able to prioritize and manage multiple activities
  • Ability to deal with ambiguity
  • Organizational savvy
  • Negotiation skills

Basic Qualifications
  • Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Top 3 Must Have Skill Sets:        
  • Use of document archival systems/electronic document repositories (Veeva RIM)
  • Knowledge of FDA clinical regulatory submissions including IND, sIND, BLA, and sBLA
  • Self-regulating prioritization and time management skills.

DAY TO DAY RESPONSIBILITIES / FIRST 30 DAYS:
  • Previous Regulatory Experience. Knowledge of FDA. Degree in life sciences. Good communication skills - both oral and written.
  • Ability to understand and communicate scientific/clinical information, Organizational skills. Knowledge of clinical regulatory submissions including IND, sIND, BLA, and sBLA useful. Use of document archival systems/electronic document repositories also useful.

Pay Rate - between $39 - $43/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"

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