Partner Therapeutics is committed to improving the lives of patients with cancer and other serious illnesses.

Regulatory Operations Manager

ComplianceComplianceFull TimeRemoteTeam 51-200H1B No SponsorCompany Site LinkedIn

Location

Washington

Posted

80 days ago

Salary

$123.5K - $150K / year

High School8 yrs expEnglishVault

Job Description

• Provides operational oversight and support for planning, preparation, tracking, publishing, QC, validation, and timely submission of eCTD submissions. • Independently develops regulatory submission documents, ensuring accuracy of content. • Leads and coordinates cross-functional teams during routine right-to-operate submissions. • Ensures applications and dossiers are prepared to the highest quality standards. • Trains and supports internal and external RIM system contributors on author and review processes. • Develops and implements standards for publishing, archiving, metrics, and submission processes. • Manages and indexes archival activities of regulatory submissions.

Job Requirements

8+ years of progressively responsible regulatory affairs/regulatory operations experience in the pharmaceutical or biotechnology industry.
Regulatory submissions knowledge, both pre- and post-marketing.
Specific knowledge of clinical and CMC are required; familiarity with labeling submissions is desirable.
Direct experience interacting with FDA is desirable.
Effective written, oral, and interpersonal skills are required for this highly collaborative role.
Excellent soft skills including a bias towards action, a constructive attitude, and adaptability.
Resourceful with proven ability to lead, manage and leverage an extensive internal network.
Strong organizational skills to manage multiple submissions.
Proven ability to plan, develop, evaluate, analyze, and interpret reports for regulatory submissions.
Demonstrated sound problem-solving skills including using creative approaches to resolve unique issues.
Familiarity with Veeva Vault – RIM, Sharepoint, and publishing software strongly preferred.
Sophisticated MS Office skills required, especially Word and Excel.