Associate Regulatory Affairs Strategy Director

Exelixis•Alameda, CA

About The Position

SUMMARY/JOB PURPOSE: Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies. ESSENTIAL DUTIES AND RESPONSIBILITIES: Interact directly with regulatory authorities. Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways. Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs. Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions. Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy. Coordinate, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations. Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/ DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA). Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs. Lead multiple assets and/or studies as assigned. Liaise internally with members of Exelixis’ functional departments. Liaise externally with vendors, licensors, consultants, and joint development collaborators.

Requirements

Bachelor’s degree in related discipline and a minimum of eleven years of related experience; or,
Master’s degree in related discipline and a minimum of nine years of related experience; or,
PhD degree in related discipline and a minimum of five years of related experience; or,
Equivalent combination of education and experience.
Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results.
Takes pride in delivering high quality work.
Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work.
Demonstrates clear and effective verbal and written communication.
Provides timely and appropriate information updates.
Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues.
Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.
Manages effectively performing teams to achieve common objectives.
Engages internal stakeholders to establish productive collaborative relationships.
Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.
Capable of managing the execution of multiple tasks.
Ensures appropriate prioritization and execution for area of responsibility.
Proactively anticipates, prioritizes and resolves task-related challenges.
Designs and implements solutions to address task-related challenges, taking into consideration the broader impact.

Responsibilities

Interact directly with regulatory authorities.
Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams.
Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
Coordinate, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/ DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
Lead multiple assets and/or studies as assigned.
Liaise internally with members of Exelixis’ functional departments.
Liaise externally with vendors, licensors, consultants, and joint development collaborators.