Senior Manager, Regulatory Affairs - Device (Onsite or Remote)

Job Title AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

Job Description

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Additional Responsibilities Include:

• Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations, and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Responds to global regulatory information requests.
• Develops strategies for device agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Represents RA Device on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization.
• Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA Device. To be successful in this role you should have:
• Knowledge of the ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications.
• Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.
• Understanding of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products. This role does have remote flexibility or can be based in AbbVie's Lake County, IL or Irvine, CA offices on a hybrid schedule.

Qualifications

• Required Education: Bachelor's Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• Required Experience: 8 years pharmaceutical experience
• Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing successful global regulatory strategies and working in a complex and matrix environment.
• Strong oral and written communication skills. Note: Higher education may compensate for years of experience Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $121,000 - $230,000
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), m

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