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Regeneron
Regeneron
H1B वीज़ा प्रायोजकजैव प्रौद्योगिकीविनिर्माणस्वास्थ्य सेवा
Regeneron एक जैव-प्रौद्योगिकी कंपनी है जो गंभीर और उपेक्षित स्वास्थ्य समस्याओं के लिए दवाओं की खोज, विकास और व्यावसायीकरण करती है। इसका अनुसंधान एलर्जी, हृदय एवं चयापचय संबंधी रोगों, तंत्रिका-विज्ञान, कैंसर-विज्ञान, रक्त-विज्ञान, नेत्र-विज्ञान और दुर्लभ रोगों तक फैला हुआ है। जैविक अनुसंधान को उन्नत प्रौद्योगिकी के साथ जोड़कर Regeneron जटिल स्वास्थ्य देखभाल आवश्यकताओं को पूरा करने के उद्देश्य से जैविक और आनुवंशिक औषधियों पर काम करती है। रोगी देखभाल को आगे बढ़ाने के अपने व्यापक मिशन के तहत कंपनी स्वास्थ्य समानता, पर्यावरणीय जिम्मेदारी, वैज्ञानिक शिक्षा और नैतिक कॉर्पोरेट प्रथाओं पर भी जोर देती है।
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कंपनी की नौकरियाँ

CMC Regulatory Affairs Manager — Regeneron (Hybrid)

Manage CMC regulatory strategy for biologics at Regeneron, supporting development, submissions, and compliance. Coordinate global strategies and health authority interactions for medicines.

USसंयुक्त राज्यNJन्यू जर्सी
$1,08,000 – $1,76,000 / वर्ष
हाइब्रिडपूर्णकालिकमध्य स्तरवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

विवरण

  • Lead CMC regulatory strategies for assigned biologic products
  • Support CMC development from early stages through submissions and post-market activities
  • Evaluate changes and deviations for regulatory impact and filing needs
  • Review regulatory submissions for alignment with applicable regulations and guidance
  • Assist with health authority engagement, including meetings and responses to information requests
  • Create work instructions, SOPs, and reviewer guides to promote consistent practices
  • Spot regulatory process gaps and propose ways to improve efficiency
  • Turn unclear issues into practical next steps and build agreement across teams
  • Work with Global Regulatory Affairs and CMC partners
  • Contribute to training and help address technical or regulatory knowledge gaps

आवश्यकताएँ

  • Bachelor’s degree plus at least 6 years of experience, or an advanced degree plus at least 3 years, in pharmaceutical, biotechnology, or health authority settings
  • 2–4 years of CMC Regulatory Affairs experience involving regulations worldwide
  • Strong knowledge of global CMC Regulatory Affairs requirements
  • Experience preparing CMC sections for marketing authorizations, CTA/INDs, and post-approval submissions
  • Experience supporting biologic products is preferred
  • Experience working with the FDA or other regulatory authorities is preferred
  • Strong communication, negotiation, strategic thinking, and problem-solving abilities
  • Ability to build cross-functional partnerships, balance competing priorities, and deliver results in changing environments
  • Ability to contribute to training and proactively address technical or regulatory knowledge gaps
  • Background screening may include identity, work authorization, and education verification

लाभ

  • Annual bonuses or other incentive programs
  • Equity awards
  • Pension or retirement benefits
  • Company matching contributions to a 401(k)
  • Health and wellness programs
  • On-site fitness centers
  • Medical, dental, vision, life, and disability insurance
  • Paid leave
  • Family support programs
  • Reasonable accommodations during recruitment where required

संबंधित नौकरियाँ

Marsh McLennan

National Employee Health and Benefits Compliance Consultant

Marsh McLennan
H1B वीज़ा प्रायोजककानूनीवित्तविपणन
USसंयुक्त राज्य
$89,500 – $1,66,900 / वर्ष
हाइब्रिडपूर्णकालिकमध्य स्तरवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

Advise Marsh McLennan Agency clients on U.S. employee health and benefits compliance. Support compliance education, training, research, and client presentations.

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CVS Health

CVS Health Business Compliance Manager, Requests for Information

CVS Health
खुदरास्वास्थ्य बीमास्वास्थ्य सेवा
USसंयुक्त राज्यALअलबामाAZएरिज़ोनाCTकनेक्टिकटFLफ़्लोरिडाKSकंसासKYकेंटकीLAलुइज़ियानाNJन्यू जर्सीNCउत्तरी कैरोलिनाOHओहायोOKओक्लाहोमाPAपेंसिल्वेनियाRIरोड आइलैंडTNटेनेसीTXटेक्सास
$66,330 – $1,45,860 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठलीडआवश्यक भाषा: अंग्रेज़ीअनुपालन

Oversee regulatory information requests across CVS Health operations and jurisdictions. Lead analysts and coordinate compliant responses with Legal, Compliance, and Operations.

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Johnson & Johnson

Director, North America Regulatory Affairs

Johnson & Johnson
H1B वीज़ा प्रायोजकऔषधियाँजैव प्रौद्योगिकीस्वास्थ्य सेवा
USसंयुक्त राज्यNJन्यू जर्सीPAपेंसिल्वेनिया
$1,64,000 – $2,82,900 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

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

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Johnson & Johnson

Director, North America Regulatory Affairs

Johnson & Johnson
H1B वीज़ा प्रायोजकऔषधियाँस्वास्थ्य बीमास्वास्थ्य सेवा
USसंयुक्त राज्यNJन्यू जर्सीPAपेंसिल्वेनिया
$1,64,000 – $2,82,900 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

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

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Medicaid Compliance Analyst

CVS Health
खुदरास्वास्थ्य बीमास्वास्थ्य सेवा
USसंयुक्त राज्य
$43,888 – $1,02,081 / वर्ष
हाइब्रिडपूर्णकालिकजूनियरमध्य स्तरआवश्यक भाषा: अंग्रेज़ीअनुपालन

Support CVS Health’s managed care compliance program by tracking regulatory deliverables, audits, risk mitigation, and state Medicaid obligations.

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