The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products. This role includes the lead regulatory responsibility for support of US and global registration and life cycle support, and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating support via a Global Regulatory Strategy Team composed of core regulatory support functions.
Designs and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations.
Serves as the US and global regulatory strategy lead for assigned projects. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Proactively identify and assesses regulatory risks associated with product development for assigned projects.
Leads Global Regulatory Team and represents regulatory affairs function on key internal program teams.
Coordinates cross-functional group of regulatory professionals as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.
The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products. This role includes the lead regulatory responsibility for support of US and global registration and life cycle support, and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating support via a Global Regulatory Strategy Team composed of core regulatory support functions.
Responsibilities
% of Time
Job Function and Description
50%
Serves as the US and global regulatory strategy lead for assigned projects. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Proactively identify and assesses regulatory risks associated with product development for assigned projects.
Leads Global Regulatory Team and represents regulatory affairs function on key internal program teams.
Coordinates cross-functional group of regulatory professionals as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.
25%
Leads the development of strategic plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
Designs and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations.
15%
Serves as corporate liaison to FDA to develop effective professional relationships as well as positive company image.
Effectively leads key meetings with US and International HAs to ensure full discussion of issues and opportunities.
5%
Provides guidance to all appropriate departments in Shire to assure compliance with applicable regulations.
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate
Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
5%
May train/mentor junior staff.
Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
Education and Experience Requirements
Bachelor’s or Master’s degree required. Advanced degree in science or healthcare or equivalent relevant experience preferred.
Generally has 8+ years of Regulatory Affairs experience. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as the US, EU, Japan and Canada) to ensure ability to provide expert regulatory oversight and guidance for assigned programs.
Key Skills, Abilities, and Competencies
Demonstrated ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
Develops corporate and/or organizational policies and authorizes the implementation of these policies.
Responsible for the successful operation of activities of major significance to the organization.
Represents the organizational unit as prime internal and external contact for GRA
Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s), supported by the local staff.
Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
Experienced in responding to inquiries or complaints from HAs.
Ability to present complex issues in oral and written form.
Proven ability to work successfully with cross-functional teams and influence appropriate plans and actions.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Excellent interpersonal, communication, analytical, managerial, and organizational skills.
Ability to effectively present information to senior management, public groups, and other departments.
Demonstrated ability to motivate, mentor and manage a team in a matrix environment.
Consistently demonstrates and models Shire core values.
Complexity and Problem Solving
Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
Global regulatory strategy and implementation; budget input; defining strategic priorities.
Internal and External Contacts
Represents the organizational unit as prime internal and external contact on contracts or operations. Interacts with equivalent level managers concerning matters of significance to the company. Conduct briefings / meetings for top management.
Strong interaction with leadership in global regulatory affairs and development functions and senior business unit leadership.
Other Job Requirements
Likely to involve some domestic and international travel.
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