Shire Senior Director Regulatory CMC in Lexington, Massachusetts

The Senior Director, CMC Regulatory Affairs 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

  • leading teams with regulatory responsibility for support of global registration and life cycle support, and CMC regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.).

  • partnering with Global Regulatory Teams composed of other regulatory support functions

  • partnering with Tech Ops Product Teams composed of core tech ops functions

  • The Senior Director CMC Regulatory Affairs leads and directs their team members to be the key interface between GRA and Tech Ops.

Responsibilities

% of Time Job Function and Description

20%

  • Creates and implements CMC regulatory strategies for clinical, marketing applications and post approval submissions. The Senior Director CMC Regulatory Affairs oversees the work of CMC Leads who are the single point of contact and have accountability for global regulatory CMC affairs, lead the regulatory CMC subteams as well as represents regulatory on key internal decision making teams such as the GRTs and PDTS/TOPTs.

  • Proactively partners with Tech Ops counterparts on processes and program prioritization.

20%

  • Proactively partners with the GRL on the development of the global regulatory strategy for assigned products

  • Functions as the global regulatory CMC lead for assigned projects, working with other GRA colleagues as part of the Global Regulatory Team, including the GRL, Operations, Labeling, International, Advertising/Promotion and Intel/Policy to drive global regulatory strategies.

  • Provides proactive guidance to internal groups (Tech Ops, Commercial) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects.

15%

  • Leads the development of strategic CMC plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.

10%

  • Serves as corporate liaison for CMC with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.

  • Effectively leads key meetings with HAs to ensure full discussion of issues and opportunities.

10%

  • 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.

  • Leads and/or participates in GRA and Tech Ops initiatives to improve processes and ways of working, keeping Shire contemporary in its approaches to regulatory strategy and submissions globally

10%

  • Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff.

5%

  • Makes recommendations for regulatory department operating procedures.May be responsible for creating and reviewing SOPs as needed.

10%

  • May supervise a number of Regulatory Affairs team members.

  • Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff.

Education and Experience Requirements

  • BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.

  • Generally has at least 10 years of Regulatory CMC experience as well as additional experience in the biopharmaceutical industry in other areas. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as US, EU, Japan and Canada) to ensure appropriate leadership and mentoring for regulatory staff within Shire.

  • 7 plus years of management experience preferred

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.

  • Develops corporate and/or organizational policies and authorizes their implementation. Provides direction to directors, senior managers in various areas and/or groups. Recognized as an influential leader.

  • Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and directions for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company’s goals.

  • Responsible for the overall surveillance and operation success of assigned functions and for successfully integrating these activities with those of other major organizational segments.

  • Represents the organizational unit as prime internal and external GRA contact with Tech Ops

  • 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.

  • 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; personnel hiring and deployment decisions as well as their supervision; 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.

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.