Senior Manager, Regulatory Documentation and Operations

ComplianceComplianceFull TimeRemoteTeam 11-50H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

65 days ago

Salary

Not specified

Bachelor Degree7 yrs expEnglish

Job Description

• Able and willing to do hands on document formatting and regulatory publishing. • Responsible for all documents and submissions to be error free from a regulatory validation standpoint with submissions made on time to meet any internal or external requirements. • Responsible and accountable for implementing SOPs and work processes for documentation, publishing, submissions and archiving. • Works with regulatory strategists and CMC strategists and project team members to execute the regulatory strategy.

Job Requirements

BA/BS degree required with 7+ years of pharmaceutical industry experience with 5+ years in regulatory affairs
Knowledge of FDA submission expectations is required. Additional experience with ex-US is preferred.
Must be solution oriented.
Must be able to handle all aspects of regulatory operations (document and submission processing)
Must have solid experience using Word and PDF files utilizing Veeva RIM and DocuBridge systems
Have successfully completed IND and/or NDA/BLA submissions activities. Preferred if also handled medical device submissions and post-approval activities.
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model.
Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.