Senior Manager, Regulatory Operations

Role Summary:

The Sr. Manager, Regulatory Operations will have primary responsibility for the Regulatory Operations function with Spyre, including regulatory submission planning, project management, vendor oversight, document management, systems/processes and representing these aspects to the wider organization. This position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development within the Regulatory function.

Key Responsibilities:

• Oversees and manages all regulatory submissions and submission compliance.
• Works on all aspects of creating (i.e., template management and workflow administration), publishing, submitting, and archiving regulatory submissions to various Health Authorities. Ensures consistency, completeness, and adherence to internal standards for all regulatory submissions.
• Manages the activities of external publishing staff contracted to publish and dispatch health authority submissions.
• Develops, implements, and maintains regulatory standards and best practices for dossier management, publishing, and archiving and provides training to submission contributors.
• Evaluates regulatory systems and proposes improvements, if needed. Manages selection, implementation, and maintenance of all Regulatory support systems, including systems subject to computer system validation.
• Leads or contributes to overall regulatory project management activities, such as submission planning, timelines, and portfolio level tracking.
• Other duties as assigned. 

Ideal Candidate:

• Bachelor’s degree with 8+ years of experience in Regulatory Operations environment within the pharmaceutical industry, with a focus on eCTD dossier management is preferred. In lieu of a degree 10 years of related industry experience is required.
• Experience managing multiple active applications.
• Experience with ex-US regulatory submissions requirements and processes, including EU-CTR, Canada, Eastern Europe, Latin America, and APAC.
• Advanced user of Microsoft suite and Smartsheets.
• Demonstrates a willingness to learn new skills and contribute to the team efforts in new ways.
• Experience with Veeva RIM systems (either as a user or, ideally, as a system administrator) and SharePoint a plus.
• Familiarity with computer system validation for FDA/EMA regulated systems a plus.
• Understanding of xml and SPL in relation to FDA submissions a plus.

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $170,000 to $191,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.