Director, Regulatory Affairs Devices and Combination Products

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

Qualifications

• 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.

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