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Shionogi Inc. (U.S.)
Shionogi Inc. (U.S.)
501 – 1.000 Angajați
Asistență medicalăBiotehnologieIndustria prelucrătoare
Shionogi Inc. (U.S.) este o companie farmaceutică și de biotehnologie axată pe dezvoltarea unor tratamente pentru boli complexe. Activitatea sa de cercetare și dezvoltare include antibiotice și medicamente antivirale inovatoare, acordând o atenție deosebită priorităților globale de sănătate, precum rezistența antimicrobiană și COVID-19. Compania reunește expertiză științifică și colaborări externe pentru a promova noi soluții în domeniul sănătății, oferind oportunități profesioniștilor interesați de cercetarea farmaceutică, dezvoltarea medicamentelor și inovația medicală.
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Senior Manager, Regulatory Program Support

Lead regulatory submission planning and execution for Shionogi’s pharmaceutical development and commercial programs. Coordinate documents, labeling, timelines, and lifecycle activities across teams.

USStatele Unite ale AmericiiNJNew Jersey
140.000 $ – 170.000 $ / an
HibridNormă întreagăSeniorLimbă Obligatorie: englezăConformitate

Descriere

  • Deliver assigned regulatory submissions from planning through completion.
  • Prepare, coordinate, review, and submit regulatory documents.
  • Act as the operational contact for designated applications and support IND and NDA lifecycle maintenance.
  • Build and refine submission plans, sequence work, and resolve dependencies across teams.
  • Check documents for completeness, consistency, readability, formatting, links, cross-references, submission readiness, and technical compliance.
  • Draft submission sections and perform quality checks for major regulatory filings.
  • Manage regulatory records and archiving.
  • Maintain regulatory schedules, trackers, submission plans, risk logs, and investigator trackers.
  • Monitor regulatory actions, commitments, information requests, and post-submission work.
  • Coordinate cross-functional meetings, records, action items, and follow-up.
  • Build and maintain detailed master schedules for INDs, NDAs, and MAAs.
  • Draft, update, annotate, and quality-check labeling throughout development, submission, approval, and implementation.
  • Represent Regulatory Affairs on clinical study teams.
  • Complete regulatory activities related to Trial Master Files.
  • Lead or support improvements to regulatory processes and tools.
  • Mentor junior colleagues and lead operations for priority programs or major submissions.

Cerințe

  • Bachelor’s degree in a scientific or related field.
  • At least five years of experience in pharmaceuticals, biotechnology, or a related industry, including substantial work in regulatory affairs, submission management, or regulatory program support.
  • Experience supporting global regulatory submissions and lifecycle management.
  • Experience coordinating regulatory deliverables across functions.
  • Experience managing complex schedules and dependencies.
  • Experience leading operational execution for development or commercial programs.
  • Working knowledge of U.S. regulatory requirements, submission processes, and IND/NDA lifecycle maintenance.
  • Strong planning and organizational abilities.
  • Sound operational judgment, including knowing when to escalate issues for regulatory or management decisions.
  • Ability to anticipate delivery risks and plan mitigations.
  • Effective communication and influence across teams.
  • Strong documentation and quality-control skills, with attention to detail, version control, and submission readiness.
  • Ability to guide and mentor less-experienced colleagues.
  • Proficiency with document management systems, project planning tools, and standard office software.
  • Willingness and ability to travel about 10% of the year, domestically and internationally.
  • Must live within commuting distance of Shionogi’s U.S. Corporate Headquarters in Florham Park, New Jersey.
  • Must be present in the office at least 50% of each month.

Beneficii

  • Comprehensive benefits package.
  • Bonus.
  • Long-term incentive.
  • Applicable allowances.
  • Approximately 10% domestic and international travel.

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