Shire Global Regulatory Lead in Cambridge, Massachusetts

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.


% of Time

Job Function and Description


  • 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.


  • 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.


  • 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.


  • 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.


  • 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.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.