Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device

Regulatory Jobs; North Chicago (IL); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to develop and implement regulatory strategies for on-market products and development projects. You will ensure alignment with the Global Regulatory Product Team (GRPT) and manage FDA interactions to enable timely regulatory approvals.

The role requires an advanced degree (or regulatory certification) and 5+ years in regulatory/R&D with medical devices, digital health, and matrix leadership.

Qualifications

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification.
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Responsabilités

• Leads regulatory strategy for US and Canada for assigned products within a Therapeutic Area and supports GRL in development and execution of regulatory strategy.
• Manages lifecycle activities including product/manufacturing change assessments, post-approval requirements, and FDA interactions; coordinates regulatory submissions and responses.
• Interfaces with FDA and other Health Authorities; coordinates briefing packages and regulatory responses.
• Advises internal teams on Regulatory/FDA issues and maintains compliance with regulatory standards.
• Operates independently within area of responsibility with minimal direction and manages workflow.

Connaissances

Regulatory strategy

Cross-functional collaboration

Negotiation skills

Communication skills

Problem solving

Regulatory liaison

Formation

Advanced degree or Regulatory certification

PharmD/PhD/MS

Description du poste

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

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The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy. Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
• Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
• Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel. May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Operates independently, with recognition of when to consult management. Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review. Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Presents pertinent regulatory information to appropriate cross-functional teams.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Minimum Qualifications:

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Global regulatory experience is a plus.

Other Required Skills:

• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.