Global Regulatory Portfolio Lead

Biogen SANDBOX•Cambridge, MA

About The Position

The Global Regulatory Portfolio Lead will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Candidate will be responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. They will also represent the company with domestic and international regulatory authorities, contractors and corporate partners, and provide regulatory support for various departments, projects, and teams/committees. Successful hire will lead a global regulatory team within Therapeutic Area. Previous experience in Gene Therapy is highly recommended. The Global Regulatory Portfolio Lead will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Successful candidate will lead a global regulatory team within a specific Therapeutic Area. Previous experience in Gene Therapy is highly recommended.

Requirements

12 years pharmaceutical/biotechnology industry experience with technical management experience.
Minimum of 10 years in Regulatory Affairs.
Comprehensive knowledge of applicable regulations.
Experience in interpretation of regulations, guidelin

Nice To Haves

Previous experience in Gene Therapy is highly recommended.

Responsibilities

Responsible for directing global regulatory strategies for assigned projects and programs integrating regional requirements (US, EU, JP, China, ICH, etc.).
Direct global clinical and pre-clinical regulatory strategies.
Direct global life cycle management of products.
Support development of the late stage clinical development plan.
Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
Provide regulatory guidance to company personnel throughout the research and development process.
Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages.
Develop and maintain the Core Data Sheet and lead global labeling team meetings.
Advise on global CTA submission strategy.
Direct the organization and preparation of clear and effective submissions.
Prepare and deliver effective presentations for external and internal audience.
Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
Mentor Regulatory Leads and guide direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports.
Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
Provide input to Regulatory Senior Management teams and Governance Committees.
Maintain a global view as part of the whole regulatory team.
Define and implement agile and pioneering strategies for Gene Therapy products ensuring consistent regulatory standards and compliance across programs.
Take steps to actively improve interdepartmental communications.
Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
May have presence on external regulatory committees/trade associations.