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BD
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BD (Becton, Dickinson and Company) develops medical technology for healthcare providers, laboratories, and patients worldwide. Its portfolio spans medication management, drug delivery, surgical care, cervical cancer screening, laboratory services, and infection risk management. The company also delivers clinical insights designed to support safer, more efficient care and better patient outcomes. BD’s work combines healthcare technology, manufacturing, and service capabilities across areas of global health and sustainability.
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Staff Regulatory Affairs Specialist – Pharmaceuticals at BD

Lead FDA submissions, compliance activities, and regulatory strategy for BD’s pharmaceutical and combination products. Collaborate with R&D, Quality, Manufacturing, Medical Affairs, Marketing, and Commercial teams.

USUnited StatesILIllinoisNJNew JerseyRIRhode Island
$117,800 – $188,600 / year
On-siteFull-timeLeadEnglish RequiredCompliance
ERP

Description

  • Oversee regulatory activities for new and existing combination devices and pharmaceutical products, including healthcare antiseptics
  • Assess CMC changes and assign reporting categories under FDA guidance for approved (A)NDA products
  • Prepare US drug submissions, including NDA, ANDA, PAS, CBE, annual reports, INDs, IND amendments, and responses to regulatory authorities
  • Define submission deliverables and coordinate with functional representatives to support accurate, timely filings
  • Collaborate with Marketing, R&D, Manufacturing, Medical Affairs, and Quality on regulatory strategy and product-change assessments
  • Deliver written and verbal regulatory updates and strategic recommendations to leadership
  • Review and approve labeling and promotional materials for compliance with internal procedures
  • Maintain drug registrations and listings in CDER Direct/eDRLS and complete CARES Act reporting
  • Support US drug-labeling SPL submissions through ESG/CDER Direct
  • Develop and assess procedures for corporate and departmental regulatory operations
  • Track regulatory obligations and maintain compliance with internal standards and external guidance
  • Support quality-system activities and internal and external audits
  • Develop and maintain working relationships with CDER
  • Advise the team on pharmaceutical and combination-product regulations, processes, and best practices

Requirements

  • Bachelor of Science degree in a field such as Chemistry, Biology, Microbiology, or Engineering
  • At least five years of Regulatory Affairs experience with combination products and/or pharmaceuticals
  • Direct experience working with FDA CDER
  • Strong knowledge of US and international regulations and guidance, including 21 CFR 820, ISO 13485, ICH guidelines, and 21 CFR 210/211
  • Demonstrated success with regulatory submissions and FDA CDER meetings
  • Ability to manage regulatory submission projects with minimal supervision
  • Strong organizational and communication capabilities
  • Ability to work independently while contributing to project teams
  • Ability to explain complex problems and issues clearly and concisely
  • Ability to manage multiple priorities and regulatory submission projects simultaneously
  • Required proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Pro
  • Experience using FDA databases
  • Experience with electronic submissions and ERP systems preferred
  • Exceptional attention to detail
  • Strong verbal, written, presentation, and communication skills
  • Ability to coordinate and compile comprehensive documentation
  • Ability to influence without formal authority and collaborate across functions
  • Relationship-building skills
  • Internal auditing experience is a plus
  • Willingness to travel 10–20%

Benefits

  • Annual bonus eligibility
  • Potential discretionary long-term incentive bonus
  • Medical coverage
  • Health Savings Accounts
  • Flexible Spending Accounts
  • Dental coverage
  • Vision coverage
  • Hospital care insurance
  • Critical illness insurance
  • Accidental injury insurance
  • Life and AD&D insurance
  • Short-term disability coverage
  • Long-term disability insurance
  • Long-term care with life insurance
  • Anxiety management program
  • Wellness incentives
  • Sleep improvement program
  • Diabetes management program
  • Virtual physical therapy
  • Emotional and mental health support programs
  • Weight management programs
  • Gastrointestinal health program
  • Substance use management program
  • Benefits for musculoskeletal surgery, cancer treatment, and bariatric surgery
  • BD 401(k) Plan
  • BD Deferred Compensation and Restoration Plan
  • 529 College Savings Plan
  • Financial counseling
  • Baxter Credit Union (BCU)
  • Daily Pay
  • College financial aid and application guidance
  • Paid time off, including all required state leaves
  • Educational assistance and tuition reimbursement
  • MetLife Legal Plan
  • Group auto and home insurance
  • Pet insurance
  • Commuter benefits
  • Product and service discounts
  • Academic Achievement Scholarship
  • Service Recognition Awards
  • Employer-matched donations
  • Workplace accommodations
  • Adoption assistance
  • Backup daycare and eldercare
  • Support for neurodivergent adults, children, and caregivers
  • Assistance for elderly and special-needs caregiving
  • Employee Assistance Program (EAP)
  • Paid parental leave
  • Support for fertility, birthing, postpartum, and age-related hormonal changes
  • Bereavement leave
  • Military leave
  • Personal leave
  • Family and Medical Leave (FML)
  • Jury and witness duty leave
  • Comprehensive Total Rewards program
  • Reward and recognition opportunities
  • Competitive compensation and benefits programs

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