Staff Regulatory Affairs Specialist - Pharma

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

Benefits offered by this job

Annual Bonus

BD 401(k) Plan

Health and Well-being Benefits

Job summary

Becton Dickinson NA is seeking an experienced Regulatory Affairs professional to review CMC changes, prepare NDA/IND submissions, and collaborate with Marketing, R&D, Manufacturing, and Quality to align regulatory strategy. The role requires effective communication, detail orientation and project management across多 teams.

With a focus on US FDA CDER submissions and labeling approvals, you will manage registrations, CARES Act reporting, and audits, while supporting SOPs and regulatory guidelines

Qualifications

• BS in science (Chemistry, Biology, Microbiology) or engineering.
• ,

Responsibilities

• Review CMC changes and determine regulatory reporting category per FDA guidance.

Skills

Excellent organizational & comms

MS Word

Excel

PowerPoint

Adobe Acrobat Pro

FDA databases

Regulatory submissions

ERP systems

Attention to detail

Project management

Education

BS in science/engineering

MS preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat Pro

ERP systems

Job description

Job Description

We are the people who give possibilities purposeBD 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.

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)NDAWrite 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 changesProvide periodic written or verbal updates and strategy to LeadershipReview 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 relationshipGuide team on Pharma/Combination product regulations, processes & best practicesKnowledge, 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 skillsHistory of successful regulatory submissions and meetings with FDA CDERProject management of regulatory submissions with minimal guidanceEffective verbal and written presentation and communication skills Comprehensive coordination and compilation of documentationInfluence without authority; Cross functional collaborationRelationship buildingExperience:Minimum of 5 years' experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals with experience working directly with the FDA CDERStrong working knowledge of US and International regulations and guidance, such as 21 CFR 820, ISO 13485, ICH guidelines and 21 CFR 210/211Internal auditing experience a plus10-20% Travel At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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

Benefits

• Annual BonusPotential 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

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.

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under " Our Commitment to You ."