Staff Regulatory Affairs Specialist - Pharma

Becton, Dickinson and Company; Vernon Hills (IL); On-site; USD 118,000 - 189,000; Full time

Benefits offered by this job

Annual Bonus Potential

Health and well-being benefits

Medical coverage

Dental coverage

Vision coverage

Life and AD&D insurance

PTO and state leaves

Educational assistance

Job summary

Becton Dickinson is seeking an experienced Regulatory Affairs professional in the United States to manage regulatory activities for combination devices and pharmaceuticals, including domestic submissions such as NDA/ANDA and labeling approvals.

The role involves coordinating with Marketing, R&D, Manufacturing, and Quality to ensure timely submissions and adherence to FDA guidance, with a focus on CDER regulatory requirements and quality systems.

Qualifications

• Minimum BS in science (Chemistry, Biology, Microbiology or engineering); Masters preferred.
• 5+ years' experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals with FDA CDER experience.
• Experience with regulatory submissions to FDA and other authorities.
• Strong written and verbal communication; cross-functional collaboration.

Responsibilities

• Review CMC changes and determine regulatory reporting category per FDA guidance.
• Prepare domestic drug regulatory submissions (NDA, ANDA, PAS, CBE, etc.).
• Coordinate regulatory deliverables with Marketing, R&D, Manufacturing, Medical Affairs and Quality.
• Provide updates and strategy to Leadership for labeling and promotional materials.

Skills

Regulatory submissions

Project management

Communication

Independent work

Education

BS in science

MS preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat Pro

FDA databases

ERP systems

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 https://bd.com/careers.

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.