Job Description

The Executive Director, International Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy in the International region. This comprises Europe, Africa, Latin America, Asia Pacific, Middle East. Role will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs for additional development of Vertex medicines, and/or for the support of Vertex marketed products. This incumbent will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This role will be part of the International Leadership Team. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. This is a senior role who will work cross functionally to understand commercial needs across the international region and drive successful regulatory development programmes and approvals.

Key Responsibilities:

Leads the development of regulatory strategy for multiple and/or complex projects in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including for regulatory submission documents and Health Authority communications
Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy
Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices
Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time
Ensures appropriate processes are utilised within areas of responsibilities
Works to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and regulatory policy and intelligence including competitive issues that influence regulatory strategy
Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in area of expertise
May act as a deputy to the International VP head of regulatory when needed
Leads GRA functional team(s) including participating in the skill development, coaching, and performance feedback for members of the GRA functional teams
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Key Requirements:

Capable to work on an enterprise level to understand and build strategic vision to drive business forward
A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems
Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents
Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
Demonstrated technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and external environments.
Expert knowledge of relevant regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use, with demonstrated knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals
Advanced proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products
Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams.
Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development
Ability to articulate the organization’s strategic vision and core values, and successfully contribute to improving the quality of internal regulatory policies, programs and initiatives
A strong leader who demonstrates sensitivity and understanding of and ability to work across different cultures, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring.

Education and Experience:

Bachelor's degree in Life Sciences
Extensive leadership experience working in Regulatory Affairs within Biotech/ Pharma environment
Strong understanding of European regulatory processes and at least one other region's (Asia Pacific or Middle East or Latin America)
Experience of working across multiple product modalities, such as biologics or small molecule
Experience of working in medical devices or diagnostics would be preferred
Successful track record of managing multiple products in multiple regions
Ability to travel as required to International Regions and Global Headquarters.

#LI-Hybrid

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Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Vertex Pharmaceuticals

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