BioSpace
Associate Director, Regulatory Affairs CMC - Hybrid Onsite
BioSpace, North Chicago, Illinois, us, 60086
Company Description
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—immunology, oncology, neuroscience, eye care, and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.
Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. This role offers the opportunity to apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables.
This individual prepares CMC regulatory strategies that enable first‑pass approvals, develops and manages content strategy for regulatory submissions—including INDs/CTAs, amendments, new marketing applications and supplements/variations—builds and maintains relationships within the Regulatory Affairs functional areas, Operations and R&D organizations, and represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. The position serves as a strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.
Scope Of Responsibility
Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications, amendments, renewals, annual reports, supplements, and variations, responding to regulatory information.
Analyzes and interprets information that impacts regulatory decisions and seeks expert advice and technical support as required.
Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
Develops strategies for CMC agency meetings, manages preparation and content of pre‑meeting submissions, and serves as the point of contact for the regulatory agency meetings.
Manages products and change control with an understanding of regulations and company policies, analyzing and approving manufacturing change requests.
Represents CMC regulatory affairs on teams such as product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects, negotiating and influencing team members with support of management to maximize chances for first‑pass approval of regulatory submissions.
Stays abreast of regulatory procedures and changes in the regulatory climate, analyzing legislation, regulation, and guidance and providing analysis to the organization.
Develops, implements, and documents policies and procedures within the regulatory affairs department and leads internal initiatives within RA CMC.
Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
Trains, develops, and mentors individuals; may include formal supervisory responsibilities.
This role is an onsite hybrid opportunity based in AbbVie's Lake County, IL office.
Qualifications
Required Education:
Bachelor’s Degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or related subject.
Preferred Education:
Relevant advanced degree preferred; certification a plus.
Required Experience:
8 years in the pharmaceutical industry with at least 3 years of demonstrated leadership.
Preferred Experience:
10 years in the pharmaceutical industry, including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.
Experience developing and implementing successful global regulatory strategies and working with health authorities.
Experience working in a complex and matrix environment.
Strong oral and written communication skills.
Note: Higher education may compensate for years of experience.
Additional Information
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 short‑erm incentive programs.
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 remain in the Company’s sole and absolute discretion 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
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Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. This role offers the opportunity to apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables.
This individual prepares CMC regulatory strategies that enable first‑pass approvals, develops and manages content strategy for regulatory submissions—including INDs/CTAs, amendments, new marketing applications and supplements/variations—builds and maintains relationships within the Regulatory Affairs functional areas, Operations and R&D organizations, and represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. The position serves as a strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.
Scope Of Responsibility
Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications, amendments, renewals, annual reports, supplements, and variations, responding to regulatory information.
Analyzes and interprets information that impacts regulatory decisions and seeks expert advice and technical support as required.
Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
Develops strategies for CMC agency meetings, manages preparation and content of pre‑meeting submissions, and serves as the point of contact for the regulatory agency meetings.
Manages products and change control with an understanding of regulations and company policies, analyzing and approving manufacturing change requests.
Represents CMC regulatory affairs on teams such as product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects, negotiating and influencing team members with support of management to maximize chances for first‑pass approval of regulatory submissions.
Stays abreast of regulatory procedures and changes in the regulatory climate, analyzing legislation, regulation, and guidance and providing analysis to the organization.
Develops, implements, and documents policies and procedures within the regulatory affairs department and leads internal initiatives within RA CMC.
Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
Trains, develops, and mentors individuals; may include formal supervisory responsibilities.
This role is an onsite hybrid opportunity based in AbbVie's Lake County, IL office.
Qualifications
Required Education:
Bachelor’s Degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or related subject.
Preferred Education:
Relevant advanced degree preferred; certification a plus.
Required Experience:
8 years in the pharmaceutical industry with at least 3 years of demonstrated leadership.
Preferred Experience:
10 years in the pharmaceutical industry, including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.
Experience developing and implementing successful global regulatory strategies and working with health authorities.
Experience working in a complex and matrix environment.
Strong oral and written communication skills.
Note: Higher education may compensate for years of experience.
Additional Information
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 short‑erm incentive programs.
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 remain in the Company’s sole and absolute discretion 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
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