Manager, Regulatory Submission Management

About the role

Regulatory Submission Management acts as a partner for strategic planning and execution of the portfolio, to ensure global Regulatory submissions are scalable, seamless, and optimized. We are a trusted companion across Regulatory Affairs, bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together.

Responsibilities

• Manages a wide variety of global submissions, such as clinical study reports (CSRs), investigator’s brochures, DSURs, regulatory responses, original INDs and amendments.
• May represent RSM in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal strategies to achieve speed-to-filing or meet technical health authority requirements; may act as a technical and operational lead for submission execution.
• Plans and oversees assigned submissions with responsibilities including development and management of global and regional content plans and resource planning for assigned submissions.
• Acts as a Subject Matter Expert for various expertise related to RSM Core Capabilities.
• Supports regulatory maintenance activities for early development and late-stage products.
• Supports the planning and preparation activities of regulatory deliverables with direction from an RA Liaison and/or GRAD Affiliate.
• Serves as the RSM lead for small to medium regulatory submissions.
• Serves as lead submission manager and department representative across development programs.
• Organizes preparation of high-quality documents for internal stakeholders. Author documents and/or procedures for submissions such as cover letters, forms and other documents as assigned.
• Participates in development/improvement of submission standards, submission templates, and validation decision trees.
• Oversees the work of external contractors supporting deliverables and other activities.
• Acts as the primary interface with the publishing team to plan and negotiate publishing timelines and deliverables.
• Coaches, trains, and provides guidance to less experienced Submission Management colleagues.
• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

Requirements

• 6+ Years with BS/BA OR 4+ Years with MS/MA
• Significant experience in the biopharma industry is strongly preferred.
• Experience managing a broad range of submission types across multiple stages of drug development.
• Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred.

Qualifications

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Recognized as a SME in a broad range of regulatory submission types and a resource for technical advice and guidance.
• Able to advise cross-functional partners on technical health authority requirements and RSM processes to meet business goals and objectives.
• In-depth knowledge of relevant health authorities, including system, processes and regulatory requirements.
• In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes with technically compliant and rapid filings.
• Strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, Smartsheet and Sharepoint as evidenced through accomplishments in past roles.
• Ability to lead and influence submissions, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly matrixed environment.
• Ability to lead and influence submissions, projects and/or initiatives.
• When needed, ability to travel.

Skills

• Strong analytical thinking skills.
• Attention-to-detail.
• Strong communication and writing skills.
• Project management skills.
• Proficiencies with Microsoft Office suite, Smartsheet and Sharepoint.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.

Pay

The Salary Range For This Position Is Other US Locations: $123,930.00 - $160,380.00. Bay Area: $136,340.00 - $176,440.00.

Schedule

N/A