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Johnson & Johnson
Johnson & Johnson
H1B Visa SponsorHealthcareHealthcare InsurancePharmaceuticals
Johnson & Johnson is a global healthcare company working across innovative medicine and medical technology. Its teams develop solutions in oncology, immunology, neuroscience, specialty ophthalmology, interventional care, and orthopaedics, combining science and technology to address complex health needs. The company also emphasizes health equity, environmental sustainability, diversity, and inclusion as it serves providers, patients, and communities worldwide.
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Senior Manager, Regulatory Affairs – Biomaterials | Johnson & Johnson

Lead regulatory strategy for biomaterials, biologics, and combination products at Johnson & Johnson Orthopaedics. Guide submissions, external innovation reviews, and global approvals from development through product lifecycle management.

USUnited StatesMAMassachusettsPAPennsylvania
$117,000 – $201,250 / year
HybridFull-timeSeniorLeadEnglish RequiredCompliance

Description

  • Develop regulatory strategies for biomaterials, biologics, combination products, and external innovation opportunities.
  • Advise early-stage programs and support regulatory due diligence and business development.
  • Guide product development, clinical programs, submissions, approvals, launch readiness, and lifecycle management.
  • Lead regulatory engagements with authorities around the world.
  • Set Regulatory Affairs priorities and communicate objectives, risks, and recommendations.
  • Prepare and maintain BLAs, IDEs and supplements, PMAs and supplements, 510(k)s, De Novo requests, HDEs, annual reports, global change notifications, and technical documentation.
  • Set regulatory strategies for pipeline development, clinical programs, and global launch readiness.
  • Work with R&D, Quality, Clinical, Medical Affairs, Supply Chain, Commercial, Business Development, and other stakeholders.
  • Use independent judgment on complex regulatory matters and deliver key regulatory work.
  • Coach colleagues and cross-functional teams, providing leadership and technical guidance.
  • Create and deliver training on regulatory, CMC, CGMP, biologics, combination-product, and clinical investigation requirements.
  • Coordinate communications with global and regional or local regulatory agencies.
  • Ensure company policies, procedures, and practices meet regulatory requirements.
  • Help secure timely approvals and clearances, and identify capability gaps and ways to address them.
  • Lead Regulatory Affairs screening and technical due diligence for external innovation, partnerships, licensing, acquisitions, and business development.
  • Represent the Biomaterials External Innovation regulatory perspective in governance forums, partner discussions, diligence, and agency engagements.

Requirements

  • Bachelor’s degree in a scientific, engineering, pharmacy, or other relevant technical field.
  • At least 8 years of relevant experience in medical devices, biologics, pharmaceuticals, combination products, or another regulated healthcare industry.
  • Experience supporting complex product development programs.
  • Specialized knowledge of CMC and CGMP regulatory requirements.
  • Experience developing and implementing regulatory strategies aligned with business objectives.
  • BLA and IDE development, submission, or lifecycle support experience is preferred.
  • Experience evaluating early-stage external innovation, conducting regulatory due diligence, or supporting partnerships and business development is preferred.
  • An advanced degree is preferred.
  • Expertise in biologics, biomaterials, combination products, CMC, CGMP, BLA, and IDE requirements.
  • Skills in regulatory submissions, early-stage regulatory strategy, external innovation assessment, regulatory due diligence, and cross-functional collaboration.
  • Strong written and verbal communication skills.

Benefits

  • 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 residents and 56 hours for Washington residents
  • 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 placement
  • Bereavement leave: 240 hours for an immediate family member and 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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