Regulatory Operations Manager
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Job Description
Regulatory Operations Manager overseeing eCTD submissions for Partner Therapeutics. Leading cross-functional teams and developing regulatory submission standards in a remote role.
Responsibilities:
- 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.
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.
Benefits:
- Medical insurance
- Dental insurance
- Vision insurance
- Flexible Spending Account/Dependent Care Account
- Health Reimbursement Account
- Disability insurance
- Life insurance coverage
- Casual work environment
- Remote workplace program
- Pre-IPO options
- Annual cash bonuses
- 401(k) matching
- Free parking
- Seattle-area ORCA pass
- Tuition assistance
- Gym subsidy
- Wellness participation programs
- Generous vacation, sick, and holiday paid time off
- Paid shutdown between Christmas and New Year
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