Director, Regulatory Affairs Devices and Combination Products

Benefits

Additional Information

The Director Regulatory Affairs, Device is responsible for combining knowledge of scientific, regulatory and business issues to support and drive strategy for regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations. Has influence and responsibility and is a key leader and driver of regulatory policy and strategy. Influences the development and changes of regulations and guidance. Interfaces with outside regulatory agencies and trade associations and provides management with regulatory metrics and information. Individual may plan, direct, coordinate and control regulatory affairs activities related to products worldwide. May supervise others. Leads a global RA Device team in developing regulatory strategies for both development-stage and marketed products delivered with injection devices. May manage the content of global regulatory dossiers directly and reviews regulatory submissions to ensure effective data and strategy presentation to regulatory authorities. Advises internal personnel on regulatory strategies including responding to regulatory information requests. Provides strategic regulatory advice to peers in RA, R&D, and Operations. Seeks internal and external expert advice and technical support when necessary. Devises regulatory strategies for complicated scenarios (e.g., complex dosage form or multiple operational changes, aggressive timelines). Develops (or advises their team on) strategies for Device agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. They or their team member serves as the point of contact for the regulatory agency meetings and leads Device discussion with health authorities. Drives strategic change planning with Manufacturing Operations using a risk-based approach centered on assessment of potential impact to quality, safety or efficacy. 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 project teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects. Negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions. Provides oversight and strategic guidance for creation of white papers and policies to illustrate current regulatory thinking. Designs initiatives to drive business efficiencies across the organization (within or outside of the regulatory groups). Identifies opportunities for process improvements, identifies/solicits solutions and drives for implementation. Ensures enterprise culture initiatives are implemented across RA Device. Trains, develops and mentors individuals; includes formal supervisory responsibilities. Provides leadership to organizational staff by communicating and providing guidance towards achieving department objectives. Identifies engagement needs and partners with stakeholders to implement action plans accordingly. Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject Preferred Education: Relevant advanced degree preferred. Certification a plus Required Experience: 10 years device and combination product experience with 2-plus years demonstrated leadership. Preferred Experience: 10-plus years device and combination product experience, including 7-plus years in regulatory affairs or 7-plus years in Discovery, R&D, or Manufacturing Experience developing and implementing successful global regulatory strategies. Experience interfacing with Health Authority and working in complex and matrix environments. Strong oral and written communication skills. Note: Higher education may compensate for years of experience 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, ISO 14155, eCTD Module 3, ISO/IEC 62366, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for AbbVie devices and combination products. Ability to travel up to [15] % of time 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 jo