Director, Regulatory Affairs Devices and Combination Products
AbbVie
13 hours ago
Remote friendly (North Chicago, IL)
United States
$160,500 - $305,000 USD yearly
Corporate Functions
Responsibilities:
- Lead a global RA Device team to develop regulatory strategies for development-stage and marketed injection device products.
- Manage global regulatory dossier content and review regulatory submissions to ensure effective data/strategy presentation to authorities.
- Advise internal personnel on regulatory strategies, including responses to regulatory information requests; provide strategic advice across RA, R&D, and Operations.
- Develop regulatory strategies for complex scenarios (e.g., complex dosage form, multiple operational changes, aggressive timelines).
- Develop Device agency meeting strategies, manage meeting preparation and pre-meeting submissions; serve as point of contact and lead Device discussions with health authorities.
- 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; negotiate/influence to maximize first-pass approval of submissions.
- Provide oversight and strategic guidance for creation of white papers and policies reflecting current regulatory thinking.
- Design initiatives to drive business efficiencies, identify process improvements, and drive implementation.
- Train, develop, and mentor individuals, including formal supervisory responsibilities.
- Lead and guide staff toward department objectives; identify engagement needs and partner on action plans.
Qualifications:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field; advanced degree preferred; certification a plus.
- 10 years device and combination product experience with 2+ years demonstrated leadership.
- 10+ years experience preferred, including 7+ years in regulatory affairs OR 7+ years in Discovery/R&D/Manufacturing.
- Experience developing/implementing global regulatory strategies; interfacing with Health Authorities in complex matrix environments.
- Strong oral and written communication skills.
- Knowledge of ISO/CE process and global product registration; experience with eCTD tools and EDMS.
- Knowledge of global regulatory intelligence/policy and device/combination product regulations (e.g., 21 CFR, EU MDR/IVDR, ISO 13485, MDSAP, ISO 14155, ISO/IEC 62366, human factors, ISO 14971).
- Ability to travel up to 15%.
- Lead a global RA Device team to develop regulatory strategies for development-stage and marketed injection device products.
- Manage global regulatory dossier content and review regulatory submissions to ensure effective data/strategy presentation to authorities.
- Advise internal personnel on regulatory strategies, including responses to regulatory information requests; provide strategic advice across RA, R&D, and Operations.
- Develop regulatory strategies for complex scenarios (e.g., complex dosage form, multiple operational changes, aggressive timelines).
- Develop Device agency meeting strategies, manage meeting preparation and pre-meeting submissions; serve as point of contact and lead Device discussions with health authorities.
- 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; negotiate/influence to maximize first-pass approval of submissions.
- Provide oversight and strategic guidance for creation of white papers and policies reflecting current regulatory thinking.
- Design initiatives to drive business efficiencies, identify process improvements, and drive implementation.
- Train, develop, and mentor individuals, including formal supervisory responsibilities.
- Lead and guide staff toward department objectives; identify engagement needs and partner on action plans.
Qualifications:
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field; advanced degree preferred; certification a plus.
- 10 years device and combination product experience with 2+ years demonstrated leadership.
- 10+ years experience preferred, including 7+ years in regulatory affairs OR 7+ years in Discovery/R&D/Manufacturing.
- Experience developing/implementing global regulatory strategies; interfacing with Health Authorities in complex matrix environments.
- Strong oral and written communication skills.
- Knowledge of ISO/CE process and global product registration; experience with eCTD tools and EDMS.
- Knowledge of global regulatory intelligence/policy and device/combination product regulations (e.g., 21 CFR, EU MDR/IVDR, ISO 13485, MDSAP, ISO 14155, ISO/IEC 62366, human factors, ISO 14971).
- Ability to travel up to 15%.