Staff Regulatory Affairs Specialist – Pharma

. Manage regulatory activities for new and existing combination devices and/or pharmaceuticals, including healthcare antiseptic products .

Posted 10/6/2026full-timeUnited StatesLead💰 $117,800 - $188,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs for Combination Products and Pharmaceuticals, with a strong focus on FDA compliance, regulatory submissions, and cross-functional collaboration. Proficient in managing multiple projects and ensuring adherence to US and International regulations.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA CDER InteractionRegulatory Submissions ManagementKnowledge of 21 CFR RegulationsProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsFDA Guidance ComplianceCMC Change ReviewLabeling and Advertising ApprovalSPL SubmissionsRegulatory ReportingInternal AuditingDocumentation CoordinationProject ManagementRegulatory Strategy Development

Soft Skills

Excellent Communication SkillsOrganizational SkillsProblem-Solving AbilityCross-Functional CollaborationRelationship Building

Tools & Technologies

MS WordMS ExcelMS PowerPointAdobe Acrobat PROFDA DatabasesElectronic Submission SystemsERP Systems

Industry Keywords

Combination ProductsPharmaceuticalsHealthcare Antiseptic Products21 CFR 820ISO 13485ICH Guidelines21 CFR 210/211CARES Act ReportingCDER DirectEDRLS

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Manage regulatory activities for new and existing combination devices and/or pharmaceuticals, including healthcare antiseptic products
Review CMC changes and determine regulatory reporting categories according to FDA guidance for changes to approved (A)NDA products
Write domestic drug regulatory submissions, including NDA, ANDA, PAS, CBE, Annual Reports, IND, IND Amendments, and regulatory authority responses
Determine submission deliverables and communicate them to functional representatives to ensure timely and accurate submissions
Partner with Marketing, R&D, Manufacturing, Medical Affairs, and Quality on regulatory strategy and product-change impact assessments
Provide written and verbal updates and strategy to leadership
Review and approve labeling and advertising/promotional materials for compliance with internal procedures
Manage and maintain drug registrations and listings in CDER Direct/eDRLS and complete CARES Act reporting
Support SPL submissions via ESG/CDER Direct for US drug labeling
Evaluate and prepare procedures for corporate and departmental regulatory activities
Monitor regulatory requirements and ensure compliance with corporate and external standards and guidance documents
Support the quality system and internal/external audits
Maintain and build the relationship with CDER
Guide the team on pharma/combination-product regulations, processes, and best practices

Requirements

What you’ll need

Minimum BS required in science, such as Chemistry, Biology, Microbiology, or engineering
Minimum of 5 years’ experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals
Experience working directly with the FDA CDER
Strong working knowledge of US and International regulations and guidance, such as 21 CFR 820, ISO 13485, ICH guidelines, and 21 CFR 210/211
History of successful regulatory submissions and meetings with FDA CDER
Project management of regulatory submissions with minimal guidance
Excellent organizational and communication skills
Ability to work independently and support project teams
Ability to address and communicate problems and complex issues concisely and effectively
Ability to manage multiple projects/tasks simultaneously and prioritize regulatory submission projects
Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required
Experience navigating FDA databases required
Experience with electronic submissions and ERP systems preferred
Strong attention to detail
Effective verbal and written presentation and communication skills
Comprehensive coordination and compilation of documentation
Influence without authority and cross-functional collaboration
Relationship building
Internal auditing experience a plus
10–20% travel

Benefits

Comp & perks

Annual Bonus
Potential Discretionary LTI 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/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
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 (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Bereavement leaves
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