What are the responsibilities and job description for the Manager Regulatory Affairs, Global Regulatory Strategy US & Canada - Hybrid position at BioSpace?
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 Manager Regulatory Affairs, Global Regulatory Strategy US & Canada 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 assists Regulatory Staff by identifying and gathering 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) within a Therapeutic Area and supports the Manager (Senior Manager, Associate Director, Director (Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.Assigned matters may have an impact on business activities and operations.
Serves as Health Authority (HA) liaison with FDA for routine communications in support of filings including complete and timely responses during application review.Advise 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.
Key contributor responsible for 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.
Supports the regulatory submission and approval process.Applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Recommends and implements changes to projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
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).
This role will work a hybrid work schedule (3 days in office) from AbbVie Lake County, IL headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
Preferred Education: Advanced Degree a plus. Certifications a plus.
Required Experience: 6 years Regulatory, R&D, or Industry-related experience.
Preferred Experience: 2-3 years in pharmaceutical regulatory activities
Skill Set:Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus.
Experience working in a complex and matrix environment.
Skill Set cont'd:Good communication, both oral and written.
Experience interfacing with government regulatory agencies.
Demonstrates good negotiation skills and builds consensus.
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
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 Manager Regulatory Affairs, Global Regulatory Strategy US & Canada 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 assists Regulatory Staff by identifying and gathering 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) within a Therapeutic Area and supports the Manager (Senior Manager, Associate Director, Director (Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.Assigned matters may have an impact on business activities and operations.
Serves as Health Authority (HA) liaison with FDA for routine communications in support of filings including complete and timely responses during application review.Advise 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.
Key contributor responsible for 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.
Supports the regulatory submission and approval process.Applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Recommends and implements changes to projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
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).
This role will work a hybrid work schedule (3 days in office) from AbbVie Lake County, IL headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
Preferred Education: Advanced Degree a plus. Certifications a plus.
Required Experience: 6 years Regulatory, R&D, or Industry-related experience.
Preferred Experience: 2-3 years in pharmaceutical regulatory activities
Skill Set:Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus.
Experience working in a complex and matrix environment.
Skill Set cont'd:Good communication, both oral and written.
Experience interfacing with government regulatory agencies.
Demonstrates good negotiation skills and builds consensus.
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