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Johnson & Johnson
Johnson & Johnson
H1B vīzas sponsorsFarmaceitiskie produktiVeselības apdrošināšanaVeselības aprūpe
Johnson & Johnson ir globāls veselības aprūpes uzņēmums, kas darbojas inovatīvu zāļu un medicīnas tehnoloģiju jomā. Tā komandas izstrādā risinājumus onkoloģijā, imunoloģijā, neirozinātnē, specializētajā oftalmoloģijā, invazīvajā aprūpē un ortopēdijā, apvienojot zinātni un tehnoloģijas, lai risinātu sarežģītas veselības aprūpes vajadzības. Uzņēmums pievēršas arī veselības vienlīdzībai, vides ilgtspējai, daudzveidībai un iekļaušanai, apkalpojot veselības aprūpes sniedzējus, pacientus un kopienas visā pasaulē.
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Vakances uzņēmumā

Director, North America Regulatory Affairs

Lead Johnson & Johnson’s regulatory strategy for innovative medicines across North America. Oversee FDA and Health Canada submissions, labeling, compliance, and regulatory teams.

USAmerikas Savienotās ValstisNJŅūdžersijaPAPensilvānija
164 000 $ – 282 900 $ / gads
HibrīdiPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuAtbilstība

Apraksts

  • Shape and maintain regulatory strategies for North America and global programs.
  • Lead the North American Regulatory Team and guide cross-functional development teams.
  • Align regulatory plans with priorities across the product portfolio.
  • Review and oversee key regulatory submissions.
  • Lead interactions with the FDA and support engagement with health authorities.
  • Set North American content and timing for global dossiers, including BLA/NDAs, IND/CTAs, addenda, and supplements.
  • Act as the primary contact for the US FDA.
  • Lead regulatory response teams addressing FDA and Health Canada questions.
  • Advise US business partners on regulatory strategies, PMR fulfillment, and other US regulatory matters.
  • Manage routine maintenance filings and track North American post-approval commitments.
  • Review submission documents, provide input, and approve filings before they are sent to authorities.
  • Contribute to USPI development and lead North American labeling negotiations.
  • Prepare supporting labeling materials and check FDA and Health Canada labeling against the CCDS.
  • Manage people leaders and senior individual contributors in a matrixed organization.
  • Hold career development discussions and provide coaching and feedback.
  • Set Regulatory Affairs initiatives that support corporate strategy and compliance requirements.
  • Work with R&D, Marketing, and other leaders on cross-functional policies and portfolio plans.
  • Recommend product development approaches informed by expected regulatory changes and emerging issues.
  • Work with stakeholders to shape regulatory policies and positions.
  • Keep management informed about regulatory policy and changes in the operating environment.
  • Oversee team operations, including budget, performance, compliance, workforce, and succession planning.
  • Build a purpose-led environment guided by Johnson & Johnson’s Credo and Leadership Imperatives.
  • Drive and execute regulatory strategy across North American and global programs.

Prasības

  • Bachelor’s degree or equivalent in a scientific discipline.
  • At least 10 years of relevant experience.
  • Experience leading interactions with health authorities.
  • Experience in US regulatory affairs.
  • Broad knowledge and experience in drug development, from early and late-stage development through lifecycle management.
  • Ability to interpret regulatory requirements and precedent in scientific and commercial settings.
  • Working knowledge of US and EMA labeling requirements.
  • In-depth knowledge of current US FDA, Health Canada, EMA for GRL, and global regulations relevant to regulatory strategy.
  • Experience managing a multi-product portfolio.
  • Ability to operate as both a leader and individual contributor in a matrixed organization.
  • People and project management capabilities.
  • Strong written and verbal communication skills.
  • Strong organizational and multitasking abilities.
  • Sound independent judgment and the ability to resolve complex organizational issues with novel solutions.
  • Ability to incorporate input from a wide range of stakeholders.
  • Ability to improve business and work processes in support of innovation.
  • Experience in oncology, cell therapies, or other complex modalities is preferred.

Priekšrocības

  • Consolidated pension plan.
  • 401(k) savings plan.
  • Long-term incentive program.
  • 120 hours of vacation per calendar year.
  • 40 hours of sick time per calendar year; 48 hours for Colorado employees and 56 hours for Washington employees.
  • 13 paid holidays per calendar year, including floating holidays.
  • Up to 40 hours of work, personal, and family time per calendar year.
  • 480 hours of parental leave within one year of a child’s birth, adoption, or foster care placement.
  • Bereavement leave of 240 hours for an immediate family member or 40 hours for an extended family member per calendar year.
  • 80 hours of caregiver leave in a rolling 52-week period.
  • 32 hours of volunteer leave per calendar year.
  • 80 hours of military spouse time off per calendar year.

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