Staff Regulatory Affairs Specialist - Pharma
5 giorni fa
Warwick
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. 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. The ideal candidate is a Regulatory Affairs professional with 5+ years of pharmaceutical and/or combination product experience, strong direct interaction with FDA CDER, demonstrated success leading NDA/ANDA/PAS/CBE submissions, deep knowledge of FDA and global regulatory requirements, and the ability to independently manage complex regulatory projects while partnering effectively across R&D, Quality, Manufacturing, Medical Affairs, and Commercial teams. • 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, • Guide team on Pharma/Combination product regulations, processes & best practices, • 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., • Minimum BS required in science - such as Chemistry, Biology, Microbiology, or engineering. Masters Preferred., • 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, • 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 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. At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: • 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 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 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. USA IL - Vernon Hills USA NJ - Franklin Lakes, USA RI - Warwick NA (United States of America) 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". Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. $117,800.00 - $188,600.00 USD Annual #J-18808-Ljbffr
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