Director, Regulatory Affairs Devices and Combination Products
AbbVie
11 days ago
Remote friendly (Irvine, CA)
United States
$160,500 - $305,000 USD yearly
Corporate Functions
Responsibilities:
- Lead a global Regulatory Affairs (RA) Device team to develop regulatory strategies for development-stage and marketed injection-device products.
- Manage global regulatory dossier content and review submissions to ensure effective data and strategy presentation to regulatory authorities.
- Advise internal teams on regulatory strategies, including responding to regulatory information requests; provide strategic input across RA, R&D, and Operations.
- Develop regulatory strategies for complex scenarios (e.g., complex dosage forms, multiple operational changes, aggressive timelines).
- Develop/advise strategies for device agency meetings; manage pre-meeting submissions and serve as point of contact for health authority discussions.
- Drive risk-based strategic change planning with Manufacturing Operations; manage products/change control and analyze/approve manufacturing change requests.
- Represent RA Device on project teams (e.g., product development, Global Regulatory Product Teams, Operations brand teams) and negotiate to maximize first-pass submission approval.
- Provide oversight for white papers and policies reflecting current regulatory thinking.
- Design initiatives to improve business efficiencies; identify process improvements and drive implementation; ensure enterprise culture initiatives within RA Device.
- Train, develop, mentor staff; provide leadership to achieve department objectives.
Qualifications:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field.
- Preferred: advanced degree; certification a plus.
- Required: 10 years device and combination product experience with 2+ years demonstrated leadership.
- Preferred: 10+ years device/combination products; 7+ years in RA or 7+ years in Discovery/R&D/Manufacturing.
- Experience developing global regulatory strategies and interfacing with Health Authorities in complex/matrix environments.
- Strong oral and written communication skills.
- Knowledge of ISO/CE process, global product registration; eCTD tools and EDMS.
- Knowledge of global regulatory intelligence/policy and device/combination regulations (e.g., 21 CFR Parts 3/4, GCP, GLP, 210/211, 820 QSR; EU directives/regulations MDR/IVDR; ISO 13485, MDSAP, ISO 14155, eCTD Module 3, ISO/IEC 62366, ISO 14971, human factors, device complaint handling).
- Travel: up to 15%.
- Lead a global Regulatory Affairs (RA) Device team to develop regulatory strategies for development-stage and marketed injection-device products.
- Manage global regulatory dossier content and review submissions to ensure effective data and strategy presentation to regulatory authorities.
- Advise internal teams on regulatory strategies, including responding to regulatory information requests; provide strategic input across RA, R&D, and Operations.
- Develop regulatory strategies for complex scenarios (e.g., complex dosage forms, multiple operational changes, aggressive timelines).
- Develop/advise strategies for device agency meetings; manage pre-meeting submissions and serve as point of contact for health authority discussions.
- Drive risk-based strategic change planning with Manufacturing Operations; manage products/change control and analyze/approve manufacturing change requests.
- Represent RA Device on project teams (e.g., product development, Global Regulatory Product Teams, Operations brand teams) and negotiate to maximize first-pass submission approval.
- Provide oversight for white papers and policies reflecting current regulatory thinking.
- Design initiatives to improve business efficiencies; identify process improvements and drive implementation; ensure enterprise culture initiatives within RA Device.
- Train, develop, mentor staff; provide leadership to achieve department objectives.
Qualifications:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field.
- Preferred: advanced degree; certification a plus.
- Required: 10 years device and combination product experience with 2+ years demonstrated leadership.
- Preferred: 10+ years device/combination products; 7+ years in RA or 7+ years in Discovery/R&D/Manufacturing.
- Experience developing global regulatory strategies and interfacing with Health Authorities in complex/matrix environments.
- Strong oral and written communication skills.
- Knowledge of ISO/CE process, global product registration; eCTD tools and EDMS.
- Knowledge of global regulatory intelligence/policy and device/combination regulations (e.g., 21 CFR Parts 3/4, GCP, GLP, 210/211, 820 QSR; EU directives/regulations MDR/IVDR; ISO 13485, MDSAP, ISO 14155, eCTD Module 3, ISO/IEC 62366, ISO 14971, human factors, device complaint handling).
- Travel: up to 15%.