Staff Regulatory Affairs Specialist - United States
The Staff Regulatory Affairs Specialist will represent regulatory affairs within IV Fluids, WW Infusion Disposables (WWID) platform of the Medication and Procedural Solutions business unit of Becton Dickinson (BD) on new product development, sustaining engineering, and other product development initiatives. The ideal candidate will have pharmaceutical and combination device experience.
The Staff Regulatory Affairs Specialist will act as the Regulatory lead on cross-functional product development teams to achieve business goals. RA lead will provide teams with strategic and tactical guidance regarding US submission requirements to support pharmaceutical product licensing and approvals in the US and EU. The Staff Regulatory Specialist will participate in projects and give Regulatory guidance for drug products distributed by BD and will be responsible for the intercompany regulatory communication and relationships.
- Review and approve labeling/promotional/advertising materials, change order assessment and approval, and other documents to ensure compliance to the appropriate regulations.
- Coordinate preparation of meeting packages and materials for FDA and Europeans Medicines Agency, as well as consult with BD colleagues for meetings with global Ministries of Health.
- This position will support the Director of Regulatory Affairs WWID in drug and device regulatory strategy and submission through participation in meetings, design control activities/projects. This position will be responsible for supporting and maintaining the device registration and listings (FURLS) system for FDA cleared devices sold in the US as applicable.
- This position will be the contact person for all inquiries as it pertains to Global Trade and customer inquiries.
- This person will also be responsible for the system management of the RA fields for the Global Trade Import process. This individual will liaise with BD regulatory professionals outside of the US and EU to determine product licensing and approvals requirements, and communicate these requirements to the appropriate teams. This individual will liaise with Becton Dickinson regulatory associates within Medical and Procedural Solutions (MPS), as well as regulatory associates around the world to determine product licensing and approval requirements and communicate these requirements to the various teams.
- The Staff Regulatory Specialist will create regulatory strategies, review and give input about changes to ensure compliance to the appropriate regulations. This individual may prepare the appropriate regulatory submissions and/or consult with Regional RA associates when they prepare submissions, and interact with health authorities as necessary to obtain and maintain product licensing and approvals globally.
- Independently manages multiple long-term projects with direction/support from supervisor. Interacts with manager as required on activities, issues, or milestones.Inspires effective unit dynamics and imparts a sense of commitment to unit goals. Encourages and empowers others to achieve outcomes.
- Influence without authority is a critical skill for successful candidate.Formulates short-term planning for individual deliverables and participates in long term planning within the unit. Influences content in the functional scorecard, including the development and definition of measurable goals and objectives consistent with business and operating plans.
Oral & Written Communication:
Communicates (oral/written) with groups, assesses and responds to feedback. Prepares formal written regulatory strategies, reports/documents for distribution within work unit and regions. Global experience and Project Management skills desired.
Project/Task Management: As regulatory representative, manages regulatory deliverables and monitors multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas. Maintains a “focused urgency” as required by specific events.
Problem Solving & Prevention: Recognizes potential problems, including ambiguous situations by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas including corrective action to prevent recurrence.
Continuous Improvement: Suggests significant opportunities for improvement (cost, cycle time, process, quality, etc.). Analyzes feasibility, participates and possibly leads in developing, executing, or monitoring implementation plan demonstrating Strategic thinking as well as attention to detail
Training & Presentations: Provides training or presentations to cross-functional groups across BD as necessary.
Teamwork and Team Building:Proactively interacts with and guides project teams, as well as across appropriate levels of management to achieve team and business goals, while leading within Regulatory function.
Proficient in Windows based applications: SAP, MS Word, MS Excel, MS Power Point, and Adobe Acrobat. Familiar with the various FDA databases.
Regulatory Knowledge: Interprets subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
Technical (Subject Matter) Proficiency: Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes.
Education and Experience:
- Minimum of BA/BS degree is required. Preferred education/experience areas include health care, physical, biological, and regulatory sciences, clinical, engineering, potentially coupled with advanced degrees (MS, MBA, PhD, etc.)
- 3-5 years of pharmaceutical regulatory affairs experience, with medical device or combination products experienced desired.
- Must have previous experience with global submissions (China a plus), 510(k)s, Technical Files and Design Dossiers. Pre-submission meetings with health authorities a plus
- Experience working with cross-functional teams in multiple locations with high sense of urgency and execution focus