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Johnson & Johnson
Johnson & Johnson
H1B वीज़ा प्रायोजकऔषधियाँजैव प्रौद्योगिकीस्वास्थ्य सेवा
Johnson & Johnson एक वैश्विक स्वास्थ्य सेवा कंपनी है, जो फार्मास्यूटिकल्स, चिकित्सा उपकरणों और उपभोक्ता स्वास्थ्य के क्षेत्र में काम करती है। इसके अनुसंधान और उत्पाद विकास कार्यों में ऑन्कोलॉजी, इम्यूनोलॉजी, न्यूरोसाइंस और हृदय-फुफ्फुसीय स्थितियों के लिए दवाएं और उपचार शामिल हैं। साथ ही, कंपनी हृदय संबंधी देखभाल, ऑर्थोपेडिक्स, सर्जरी और दृष्टि के लिए MedTech समाधान भी विकसित करती है। इसके व्यापक कार्यों में स्वास्थ्य और कल्याण शिक्षा, बड़े पैमाने पर विनिर्माण, निवेशक गतिविधियां और वैश्विक सामाजिक प्रभाव की पहल भी शामिल हैं, जिससे वैज्ञानिक, नैदानिक, इंजीनियरिंग, विनिर्माण, वाणिज्यिक और कॉर्पोरेट कार्यों में अवसर बनते हैं।
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कंपनी की नौकरियाँ

Director, North America Regulatory Affairs

Lead Johnson & Johnson’s regulatory strategy for North American drug development and FDA engagement. Oversee submissions, labeling, health authority interactions, and regulatory teams.

USसंयुक्त राज्यNJन्यू जर्सीPAपेंसिल्वेनिया
$1,64,000 – $2,82,900 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

विवरण

  • Shape and maintain regulatory strategies for North America.
  • Develop and carry out global and North American regulatory strategies.
  • Lead the North American Regulatory Team and guide cross-functional development teams.
  • Align North American work with portfolio priorities.
  • Oversee and critically assess key regulatory submissions.
  • Lead and support engagement with the FDA.
  • Set North American content requirements and timelines for global dossiers, including BLAs, NDAs, INDs, CTAs, addenda, and supplements.
  • Act as the primary contact for the US FDA.
  • Lead teams responding to questions from the FDA and Health Canada.
  • Advise US Business Partners on US regulatory strategies, PMR fulfillment, and other US regulatory matters.
  • Manage routine maintenance submissions and track North American post-approval commitments.
  • Review and approve submission documents before they are sent to regulatory authorities.
  • Contribute to USPI development and lead North American labeling negotiations.
  • Review FDA and Health Canada labeling for consistency with the CCDS.
  • Direct managers and senior individual contributors in a matrixed organization.
  • Hold career development discussions and provide coaching and feedback.
  • Set Regulatory Affairs initiatives that align with corporate strategy and compliance requirements.
  • Work with R&D, Marketing, and other leaders on cross-functional policies and portfolio strategy.
  • Recommend product development approaches in response to expected regulatory changes and emerging issues.
  • Work with stakeholders to shape regulatory policies and positions.
  • Keep management informed about regulatory policies and changes in the regulatory environment.
  • Manage team operations, including budget, performance, compliance, staffing, and succession planning.
  • Build a purpose-driven environment guided by Johnson & Johnson’s Credo and Leadership Imperatives.

आवश्यकताएँ

  • Bachelor’s degree in a scientific or equivalent discipline.
  • At least 10 years of relevant experience.
  • Experience leading interactions with health authorities.
  • Experience with US regulatory affairs.
  • Broad knowledge and experience across drug development, from early and late development through lifecycle management.
  • Ability to interpret regulatory requirements and precedent in scientific and commercial contexts.
  • Working knowledge of US and EMA labeling requirements.
  • In-depth knowledge of current US FDA, Health Canada, and EMA requirements for GRL, as well as global regulations relevant to regulatory strategy.
  • Experience managing a portfolio of multiple products.
  • Ability to lead and contribute as an individual in a matrixed environment.
  • People and project management skills.
  • Strong written and verbal communication skills.
  • Strong organizational and multitasking skills.
  • Independent judgment and ability to resolve complex organizational issues with original solutions.
  • Oncology, cell therapy, or other complex modality experience is preferred.

लाभ

  • Consolidated pension plan.
  • 401(k) savings plan.
  • Long-term incentive program.
  • 120 vacation hours per calendar year.
  • 40 sick hours per calendar year.
  • 13 days of holiday pay, including floating holidays, per calendar year.
  • 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 placement.
  • Bereavement leave per calendar year: 240 hours for an immediate family member or 40 hours for an extended family member.
  • 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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