Manager, Regulatory Operations
we're a growing, clinical-stage biotech company located in Waltham focused on the development of novel therapeutic compounds (small molecules and peptides) to treat disease through the inhibition of the complement system, which is an integral component of the immune system. This is a direct-hire, permanent opportunity for a Manager of Regulatory Information Management.
Top Reasons to Work with Us
- We already have multiple programs in our pipeline with two in Phase III!
- We're uniquely positioned to apply immunotherapy to autoimmune diseases!
- We have ~200 employees in the company!
What You Will Be Doing
The Manager of Regulatory Information Management will review, prioritize, track and respond to user issues, service requests and inquiries, and will collaborate with IT in solving more technical user issues. The role will also have direct daily contact with global users supporting their efficient and compliant use of the RA systems. The role will be the main contact with vendors and service providers on systems related upgrades and issues and will mentor and train junior members, as needed.
What You Need for this Position
- Degree strongly preferred
- 5+ years of experience in Global Regulatory Affairs or Regulatory Operations within the pharmaceutical industry
- 2+ years business systems support experience
- Demonstrated experience managing, developing and administering electronic document management systems / EDMS (eg Veeva, SharePoint), regulatory publishing systems and regulatory tracking databases
- Working knowledge of SW system validation process and compliance concepts
- Strong knowledge of GxP, Annex 11 and 21 CFR Part 11 computerized systems
- Expert in MS Office Tools, Visio and Starting Point templates
- Experience of providing direct end-user support, training and service
- eCTD Validation tools (Lorenz eValidator, ARIM Validator, etc.)
- Other publishing and QC tools (PDF Tools, ISIToolbox, etc.)
- Acrobat-based and DocuSign electronic signature systems
- Prior experience with implementation and utilization of submission gateways (ESGs)
- Experience with other systems, eg, eTMF, PV, EDC, CTMS, QMS, AdPromo, Labeling is a plus
- Knowledge of SharePoint is desirable
- Strong knowledge of the global eCTD structure and requirements
- Familiarity with submission and drug development dossier concepts
What's In It for You
- Benefits package includes 401K matching, medical, dental, vision, life, long-term disability, 20 days PTO/vacation, and more!
- We cover full medical premiums for the employee AND their entire family!
So, if you are a Manager, Regulatory Operations with experience, please apply today!
Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work
– In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.