Senior Manager, Regulatory Strategy

Role Summary

The Senior Manager, Regulatory Strategy will be responsible for supporting product applications of all types within commercial and development projects. A Senior Manager Regulatory Affairs will be a key member of project teams and teams responsible for evaluation of product concepts.

Responsibilities

• Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios.
• Represent and coordinate regulatory information as a team member, covering CMC, clinical, labeling, and post-approval change activities.
• Provide in-depth reviews of protocols, reports, presentations, and other documents.
• Document regulatory contacts with health authorities.
• Prepare IND, NDA, and BLA submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items.
• Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions.
• Manage submission plans and timelines to ensure approvals are timely and development objectives are met.
• Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies.
• Provide risk assessments and recommendations for various regulatory scenarios.
• Participate in the electronic review and quality verification of regulatory submissions.
• Manage regulatory data and information within systems.

Qualifications

• Required: Bachelor's degree in a scientific discipline; advanced degree preferred.
• Required: Experience in Oncology within a biotech/pharma company.
• Required: Regulatory strategy experience with increasing responsibility.
• Required: Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages.
• Required: Excellent verbal and written communication skills.
• Required: Leadership ability within a multiple time zone team environment.
• Required: Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others.
• Required: Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
• Required: Some travel will be required.

Education

• Bachelor's degree in a scientific discipline; advanced degree preferred.