Newly combined with Baxalta, Shire is now the leadingglobal biotechnology company focused on serving people affected by rarediseases and highly specialized conditions. These diseases are oftenmisunderstood, undiagnosed and life-threatening. Our 22,000 employees come to work every daywith a shared mission: to develop and deliver breakthrough therapies for thehundreds of millions of people in the world affected by rare diseases and otherhigh-need conditions, and who lack effective therapies to live their lives tothe fullest.
At Shire, we are dedicated to expanding, building andsustaining leadership across our key therapeutic areas through our extensiveportfolio of products, innovative pipeline and collaborative approach toworking with diverse partners around the globe. We strive to earn and keep thetrust of our patients, their families and physicians, and all others whosupport and advance their care. Working together, the possibilities for ourpatients, healthcare partners and employees are unprecedented, with significantgrowth potential for our shareholders.
(Position can be located in Lexington, MA)
Under the direction of the Global Regulatory Lead forGene Therapy and Blood Disorders, the Global Regulatory Lead is responsible fordeveloping and directing the global regulatory strategy, objectives, policiesand programs pertaining to development and marketing of drug and/or biologicalproducts. This role includes the lead regulatory responsibility for support ofglobal registration and life cycle support, and includes the leadership ofregulatory strategy for multiple projects that extend globally (United States,EU, ROW, etc.).
•Designs and implements regulatory strategies to obtain,maintain product investigative and marketing applications, and extend productregistrations. Single point of contactand accountability for regulatory and leads the regulatory subteams as well asrepresents regulatory on key internal decision making teams such as PSTs andGDTs.
•Functions as the global regulatory lead for assignedprojects, working with a cross-departmental group of regulators to drive globalregulatory strategies.
•Provides proactive guidance to internal groups based ontechnical and regulatory knowledge towards development of strategic andtactical plans. Identify and assessregulatory risks associated with product development for assigned projects.
•Leads the development of strategic plans and tacticalimplementation leading to the creation and submission of Regulatory documents,e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevantregulatory filings.
•Actively works with Regulatory Operations and RegulatoryCMC to ensure alignment of regulatory implementation associated withsubmissions. Works with Shire GlobalRegulatory Policy & Intelligence on matters of regulatory policy relevantto Shire.
•Serves as corporate liaison with regulatory Health Authority(HA) agencies to develop effective professional relationships as well as ourpositive company image.
•Provides guidance to all appropriate departments inShire to assure compliance with applicable regulations.
•Remains knowledgeable about current regulations andguidance, interprets and notifies appropriate personnel.
•Effectively leads key meetings with HAs to ensure fulldiscussion of issues and opportunities.
•Actively trains/mentors junior staff; provides broaderguidance on regulatory interpretation to Shire staff.
•Makes recommendations for regulatory departmentoperating procedures. May be responsible for creating and reviewing SOPs asneeded.
•Supervises (directly or indirectly) a changing number ofRegulatory Affairs Managers, Associates and/or Submissions Assistants.
•BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science orhealthcare preferred or equivalent relevant experience.
•Generally has at least 8-10 years of Regulatory Affairsor equivalent experience. The regulatoryexperience should be broad to ensure appropriate leadership and mentoring forregulatory staff within Shire.
•2-4 years of management experience; or an equivalentcombination of education and experience.
•Demonstrated ability to routinely accept empowermentfrom senior leadership to proactively resolve issues and identify and championopportunities toward optimal regulatory strategies and implementation.
•Strong competency in understanding regulatoryrequirements and emerging regulatory landscape associated with the HA(s),supported by the local staff.
•Ability to read, analyze and interpret scientific andtechnical information, as well as regulatory documents.
•Experienced in responding to inquiries or complaintsfrom HAs.
•Ability to present complex issues in oral and writtenform.
•Proven ability to work successfully withcross-functional teams and influence appropriate plans and actions.
•Requires strong attention to detail in composing andproofing materials, establishing priorities, scheduling and meeting deadlines.
•Must be able to work in a fast paced environment withdemonstrated ability to juggle multiple competing tasks and demands.
•Excellent interpersonal, communication, analytical,managerial, and organizational skills.
•Ability to effectively present information to seniormanagement, public groups, and other departments.
•Demonstrated ability to motivate, mentor and manage ateam.
•Consistently demonstrates and models Shire core values.
•Works on abstract problems across functional areas ofthe business. Identifies and evaluatesfundamental issues for major functional areas through assessment of intangiblevariables.
•Global regulatory strategy and implementation; personnelhiring and deployment decisions as well as their supervision; budget input;defining strategic priorities •Represents the organizational unit as primeinternal and external contact on contracts or operations. Conducts briefings and technical meetings fortop management and customer representatives. Interacts with equivalent level managers concerning matters ofsignificance to the company.
•Strong interaction with leadership in global regulatoryaffairs and development functions and senior business unit leadership.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.