About this opportunity
BD lists this Staff Regulatory Affairs Specialist - Pharma opportunity in vernon hills, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
Job description
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us- from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
This position is responsible for managing the various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products.
General Functions, Specific Responsibilities, and Authority:
Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to an approved (A)NDA
Write domestic drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses.
Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives.
Work with functional representatives from other areas such as Marketing, R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes
Provide periodic written or verbal updates and strategy to Leadership Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures.
Manage and maintain the drug registrations and listings (CDER Direct/eDRLS) system and complete CARES Act reporting.
Support the submission of SPL via ESG/CDER Direct for all drug labeling in the US.
Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities.
Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents.
Support the quality system and internal/external audits.
Maintain and build upon CDER relationship.
Knowledge, Education, and Skills Required:
Excellent organizational and communications skills.
Candidate should be able to work independently, support project teams, to address and communicate problems and complex issues in a concise and effective manner, to manage multiple projects/tasks simultaneously, and effectively manage 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 is preferred.
Education: Minimum BS required in science - such as Chemistry, Biology, Microbiology, or engineering. Masters Preferred.
Skills: Strong attention to detail and Excellent organizational skills History of successful regulatory submissions and meetings with FDA CDER Project management of regulatory submissions with minimal guidance Effective verbal and written presentation and communication skills Comprehensive coordination and compilation of documentation Influence without authority; Cross functional collaboration Relationship building Experience: Minimum of 5 years' experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals with 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 Internal auditing experience a plus 10-20% Travel
Experience:
Minimum of 5 years' experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals with 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 Internal auditing experience a plus 10-20% Travel
Benefits specific to this role:
Annual Bonus Potential
Discretionary LTI Bonus
Health and Well-being Benefits
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
Other Well-being Resources
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
Retirement and Financial Well-being 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
Life Balance Programs 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
Other Life Balance Programs
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
Leave Programs
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave
Primary Work Location USA IL - Vernon Hills Additional Locations USA NJ - Franklin Lakes, USA RI - Warwick Work Shift NA (United States of America)
Salary Range Information
$117,800.00 - $188,600.00 USD Annual
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
We are the makers of possible. Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
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Worksite address
vernon hills, IL, 60061, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.