March 24, 2023 4:40 pm CDT

Senior Director, Global Regulatory Affairs CMC

  • Freelance
  • Anywhere

Takeda Pharmaceutical

nn By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. nn nn nn nn n Job Description n nn nAbout the role:n nnAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.nn nn nn nnJoin Takeda as a Senior Director, Global Regulatory Affairs CMC where you are accountable for the development and execution of regulatory CMC risk strategy. You will manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.nn nn nn nHow you will contribute:n n nnCombines the knowledge of scientific, technical, regulatory, and business issues to drive and execute global product strategy throughout the development and commercial lifecycle.nn n n nnDemonstrate Takeda leadership behaviors.nn n n nnGlobally influences and is considered a key opinion leader within Takeda and externally.nn n n nnParticipate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.nn n n nnInfluences changing regulations and guidance, interfaces with outside regulatory agencies and trade associations, and acts as an advisor/liaison to senior management to plan, evaluate and recommend a regulatory strategy.nn n n nnEnsures team effectiveness in a complex matrix environment.nn n n nnAble to deal with issues of critical importance provide regulatory advice and make reasoned decisions for which there may not be clear/specific regulatory guidance.nn n n nnDemonstrates Takeda leadership behaviors in leadership, problem-solving ability, flexibility, and teamwork.nn n n nnQuick to adapt strategies based on regulatory and business need changes.nn n n nnActs as CMC regulatory expert for developing regulatory advice on complex topics and sharing with influence to global project teams/task forces.nn n n nnBuilds and manages relationships through active partnering with key internal and external stakeholders.nn n n nnLead and contribute to department and business process improvements.nn n n nnEvaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams.nn n n nnEnsure that project team colleagues, line management, and partners are informed of developments, risks, and opportunities that may weigh on regulatory success.nn n n nnElevate and clearly communicate actual or potential issues to stakeholders and management.nn n n nn Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC submissions.nn n n nnRepresent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.nn n n nnSignificant staff management experience for staff professional development, as well as leading submission teams for marketing applications, clinical trial applications, and life cycle management.nn n nn nn nWhat you bring to Takeda:n n nnBS/BA Degree in a Scientific Discipline, Advanced Degree preferred.nn n n nn15+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience, strongly preferred.nn n n nnproven experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.nn n n nnExpert understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.nn n n nnExperience providing strategic regulatory guidance to drug development, registration, and post-market support teams.nn n n nnProvides regulatory advice and is able to make/communicate difficult decisions.nn n n nnDemonstrated leadership, problem-solving ability, flexibility, and teamwork.nn n n nnExcellent judgment in elevating and communicating actual or potential issues to line management.nn n n nnExcellent written and oral communication skills.nn n n nnExperience of active participation in Agency/Industry groups/forums expected.nn n nn nn n Travel Requirements: n n nnWillingness to travel to various meetings, including overnight trips.nn n n nnRequires approximately up to 10-30% travel.nn n nn nn nn nn nn EEO Statement nn nn Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. nn nn n Locations n nnBoston, MA nn nn nn n Worker Type n nnEmployee nn n Worker Sub-Type n nnRegularnn nn n Time Type n nn nnFull time




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