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

BioSpace; Irvine (CA); Presencial; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Paid time off

401(k) plan

Long-term incentive programs

Descripción de la vacante

AbbVie in Irvine, CA seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device to shape regulatory strategy, oversee submissions, and coordinate with FDA for on-market and development programs. You will align regulatory planning with business goals and cross-functional teams.

The role requires advanced degrees or regulatory certification with 5+ years in regulatory affairs, including medical devices and digital health, across US/Canada.

Formación

• Advanced degree or regulatory certification required.
• 5+ years regulatory, R&D, or equivalent experience.
• Experience in medical device space and with digital health/software.

Responsabilidades

• Lead US & Canada regulatory strategy for aesthetics device portfolio.
• Coordinate regulatory submissions and responses to Health Authorities.
• Interact with FDA and other regulatory bodies as primary liaison.
• Advise cross-functional teams on regulatory implications and timelines.
• Ensure compliance with US/Canada regulatory requirements and QDP.

Conocimientos

Negotiation skills

Effective communication

Message delivery under pressure

Educación

Advanced degree (PharmD/PhD/MS)

Regulatory certification

Descripción del empleo

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 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).

Qualifications

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.

Additional Information

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 job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html