BioSpace
Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid)
BioSpace, North Chicago, Illinois, us, 60086
Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid)
AbbVie
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.
AbbVie is a global biopharmaceutical company that invests in the development of medicines to treat diseases that have high unmet medical needs.
Job Description The Senior Manager, RA Global Regulatory Strategy US & Canada is responsible for developing and implementing US and Canada regulatory strategic and tactical planning (RSTP) for assigned on‑market products or products in development. The role ensures that regulatory strategies defined within the 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
Responsible for a product(s) or products with multiple driver indications within a therapeutic area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director) in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
Serves as HA liaison, interfaces with FDA for meetings and teleconferences, and coordinates preparation and completion of FDA meeting briefing packages and responses. Advises internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
Functions independently in negotiation and decision‑making for project‑related issues that have cross‑functional impact. Assists in the development and training of staff members.
Key contributor responsible for the preparation and review of regulatory submissions consistent with US and Canada regulatory requirements and guidelines and for assuring complete and timely response to Health Authorities during application review.
Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, and corporate policies.
Presents pertinent regulatory information to appropriate cross‑functional areas.
Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
Location & Hybrid Requirement This is a hybrid role based at AbbVie’s Lake County, IL office. Onsite expectation is typically Tuesdays, Wednesdays, and Thursdays.
Qualifications
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or related field.
Advanced degree a plus. Certificates a plus.
6+ years of regulatory, R&D, or industry‑related experience.
2‑3 years in pharmaceutical regulatory activities preferred.
Excellent negotiation and problem‑solving skills and ability to build consensus.
Effective written and oral communication skills within Regulatory and across the organization.
Ability to deliver challenging messages effectively without compromising important business relationships.
Proven skill at implementing successful US and Canada regulatory strategies in a complex and matrix environment.
Global regulatory experience a plus. Experience interfacing with government regulatory agencies.
Additional Information
Compensation range: $121,000.00 – $230,000.00. Pay may vary based on location and other factors.
Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
Eligible to participate in short‑term and long‑term incentive programs.
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.
For more information, 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
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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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.
AbbVie is a global biopharmaceutical company that invests in the development of medicines to treat diseases that have high unmet medical needs.
Job Description The Senior Manager, RA Global Regulatory Strategy US & Canada is responsible for developing and implementing US and Canada regulatory strategic and tactical planning (RSTP) for assigned on‑market products or products in development. The role ensures that regulatory strategies defined within the 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
Responsible for a product(s) or products with multiple driver indications within a therapeutic area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director) in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
Serves as HA liaison, interfaces with FDA for meetings and teleconferences, and coordinates preparation and completion of FDA meeting briefing packages and responses. Advises internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
Functions independently in negotiation and decision‑making for project‑related issues that have cross‑functional impact. Assists in the development and training of staff members.
Key contributor responsible for the preparation and review of regulatory submissions consistent with US and Canada regulatory requirements and guidelines and for assuring complete and timely response to Health Authorities during application review.
Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, and corporate policies.
Presents pertinent regulatory information to appropriate cross‑functional areas.
Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
Location & Hybrid Requirement This is a hybrid role based at AbbVie’s Lake County, IL office. Onsite expectation is typically Tuesdays, Wednesdays, and Thursdays.
Qualifications
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or related field.
Advanced degree a plus. Certificates a plus.
6+ years of regulatory, R&D, or industry‑related experience.
2‑3 years in pharmaceutical regulatory activities preferred.
Excellent negotiation and problem‑solving skills and ability to build consensus.
Effective written and oral communication skills within Regulatory and across the organization.
Ability to deliver challenging messages effectively without compromising important business relationships.
Proven skill at implementing successful US and Canada regulatory strategies in a complex and matrix environment.
Global regulatory experience a plus. Experience interfacing with government regulatory agencies.
Additional Information
Compensation range: $121,000.00 – $230,000.00. Pay may vary based on location and other factors.
Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
Eligible to participate in short‑term and long‑term incentive programs.
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.
For more information, 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
#J-18808-Ljbffr