Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
Irvine, California, United States · Hybrid
$125k–$237k/yr
Senior
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 r…
Skills: Regulatory strategy, Regulatory affairs, Medical device, Digital health, Software
Company Description Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injec…
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 r…
Skills: Analytical chemistry, Mass spectrometry, Chromatography, Method development, Method validation
Company Description About AbbVie At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables,…
Skills: Clinical education, Team leadership, Facial injectables, Staff management, Training program delivery
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 r…
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 r…
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 r…
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 r…
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 r…
Skills: Customer journey mapping, Operational excellence, Six Sigma, Process improvement, Workflow optimization
Finance Support (w/m/d) - Temporary 6 months, Teilzeit, start ASAP
Vienna, Austria · Hybrid
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Unternehmensbeschreibung 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 hav…
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Finance Support (w/m/d) - Temporary 6 months, Teilzeit, start ASAP
Vienna, Austria · Hybrid
Entry level
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 r…
Skills: Finance, Data collection, SAP, Accounts payable, Analytical skills
Sr. Scientist I (Novel Biologic Entities- Bioanalysis and Translational Science Group- QTAS)
Worcester, Massachusetts, United States · On-site
$97k–$184k/yr
Senior
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 r…
Skills: LC/MS, Bioanalysis, Protein characterization, Mass spectrometry, Pharmacokinetics
Company Description This is our MD Pack - B1 Shift: 7am-7:30pm Thursday - Saturday & every other Wednesday About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious he…
Skills: Manufacturing supervision, Safety leadership, Production scheduling, Team management, Regulatory compliance
Associate Director, Market Research and Analytics - Immunology HS
Mettawa, Illinois, United States · On-site
$142k–$269k/yr
Senior+
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 r…
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 r…
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Copy of District Manager - GI Care - Greater Kentucky (Lexington, KY, Louisville, KY, Evansville, IN, Cincinnati, OH)
Cincinnati, Ohio, United States · On-site
$110k–$209k/yr
Senior
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 r…
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District Manager - GI Care - Greater Kentucky (Lexington, KY, Louisville, KY, Evansville, IN, Cincinnati, OH)
Louisville, Kentucky, United States · On-site
$110k–$209k/yr
Senior
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 r…
Skills: Sales management, Business planning, Coaching, Mentoring, Market analysis
District Manager - GI Care - Greater Kentucky (Lexington, KY, Louisville, KY, Evansville, IN, Cincinnati, OH)
Lexington, Kentucky, United States · On-site
$110k–$209k/yr
Senior
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 r…
Skills: Sales management, Business planning, Coaching, Mentoring, Market dynamics
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 r…
District Manager - GI Care - (Greater Chicago, IL & Milwaukee, WI)
Chicago, Illinois, United States · On-site
$110k–$209k/yr
Senior
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 r…
Skills: Sales management, Business planning, Coaching, Mentoring, Market analysis
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
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$125k–$237k/yr
Full-time
postgraduate degree, professional certificate
Paid time off, Medical insurance, Dental insurance, Vision insurance, 401(k), Long-term incentive programs
Posted 2d ago
~40 hrs/week
Responsibilities
The Senior Manager leads the development and implementation of US and Canada regulatory strategies for aesthetics devices throughout the product lifecycle. They serve as the primary liaison with Health Authorities and provide strategic guidance to cross-functional teams to ensure compliance and successful commercialization.
Requirements
Candidates must hold an advanced degree such as a PharmD, PhD, or MS, or possess a relevant regulatory certification. A minimum of 5 years of experience in regulatory affairs, R&D, or a related industry, specifically within the medical device or digital health sector, is required.
Full job description
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.
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Health CareBiopharmaEducationBiotechnologyMedicalUniversitiesPharmaceutical
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Health CareBiopharmaEducationBiotechnologyMedicalUniversitiesPharmaceutical