{"id":1147663,"url":"https://alion.io/job/takeda-pharmaceutical-director-global-regulatory-affairs-cmc","title":"Director, Global Regulatory Affairs CMC","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":82,"open_postings":25,"ghost_share":0,"stale_share":0.72,"repost_share":0,"time_to_fill_p50_days":22,"computed_at":"2026-09-25T05:45:01Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":177000,"max":278080,"currency":"USD","period":"year","gross":null,"usd_annual":278080},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-22T00:00:00Z","employer_posted_date":"2026-09-22","last_verified_at":"2026-09-25T23:22:12Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"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.\nJob Description\nAbout the role:\nAt 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.\nThis role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:\nIndependently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead.\n\nRepresents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.\n\nDemonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines.\n\nApply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.\n\nStrong analytical or process understanding that enables the development of robust and accurate submissions\n\nDevelops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.\n\nSuccessfully communicates and negotiates with Health Authorities - directly and indirectly.\n\nAble to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization.\n\nActs as mentor / coach to all GRA CMC members - as required.\n\nHow you will contribute:\nDevelops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.\n\nGuide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges\n\nRepresents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters.\n\nProvide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required.\n\nFosters constructive working relationships when interacting with internal and/or external colleagues.\n\nProviding strategic input into change control evaluation - as required.\n\nAs a GRA CMC member, ensures and / or enhances regulatory compliance.\n\nEnsures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.\n\nReviews, provides regulatory CMC input and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.\n\nWhen in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities.\n\nProactively identifies regulatory CMC risks, ensuring timely communication with line management.\n\nLeads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.\n\nProvides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.\n\nWorks effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target.\n\nSupports development of strategies, tools, and trainings to further the GRA CMC roadmap.\n\nProactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.\n\nMinimum Requirements/Qualifications:\nBS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required.\n\n10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development - including preparation of NDA/NLA/MAA.\n\nEquivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.\n\nUnderstanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.\n\nProven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.\n\nAnalyze issues with attention to detail.\n\nAbility to assess alternative approaches.\n\nBase regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines\n\nAble to deal with issues of critical importance with minimal oversight.\n\nExercises good judgment in elevating and communicating actual or potential issues to line management.\n\nApplies directions taken by the company.\n\nDemonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.\n\nIntentionally promotes an inclusive culture.\n\nApplies given prioritization framework with limited support.\n\nExcellent written and oral communication skills required.\n\nExercises good judgement in elevating and communicating actual or potential issues to line management.\n\nMore about us:\nAt Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.\nCertified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.\nThis position is currently classified as \"hybrid\" following Takeda's Hybrid and Remote Work policy.\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nBoston, MAU.S. Base Salary Range:\n$177,000.00 - $278,080.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.\nFor information about our benefits, please click here.\nEEO Statement\nTakeda 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.\nLocations\nBoston, MAWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull timeJob Exempt\nYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.","description_format":"text","description_chars":8956,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-23T16:06:38Z"}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":22,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-09-25T05:45:01Z"},"pay":{"stated_usd_annual":278080,"is_top_pay":true},"html_url":"https://alion.io/job/takeda-pharmaceutical-director-global-regulatory-affairs-cmc","json_url":"https://alion.io/job/takeda-pharmaceutical-director-global-regulatory-affairs-cmc.json","meta":{"generated_at":"2026-09-26T02:26:41Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":2527,"day_limit":5000,"remaining_today":2473,"minute_limit":60,"resets_at":"2026-09-27T00:00:00Z"}}}