AbbVie
Associate Director, Regulatory Affairs CMC - Hybrid Onsite
AbbVie, North Chicago, Illinois, us, 60086
Overview
Associate Director, Regulatory Affairs CMC - Hybrid Onsite at AbbVie. This role focuses on small molecule products in development and involves developing CMC regulatory strategies, managing regulatory submissions, and liaising with regulatory agencies to enable first-pass approvals. Base pay range $137,500.00/yr - $261,000.00/yr Responsibilities
Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations; responds to regulatory information requests. Analyses and interprets information impacting regulatory decisions; seeks expert advice and technical support as required for strategies and submissions. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies. Develops strategies for CMC agency meetings, prepares for agency meetings, and manages content of pre-meeting submissions; serves as the point of contact for regulatory agency meetings. Manages products and change control with understanding of regulations and company policies; analyzes and approves manufacturing change requests. Represents CMC regulatory affairs on cross-functional teams; negotiates with and influences team members to maximize chances for first-pass approvals. Stays abreast of regulatory procedures and changes in the regulatory climate; analyzes legislation, regulation and guidance and provides analysis to the organization. Develops, implements, and documents policies and procedures within the regulatory affairs department; leads internal RA CMC initiatives. Represents CMC regulatory affairs on project initiatives with other functional areas to drive cross-functional efficiencies. Trains, develops, and mentors individuals; may include formal supervisory responsibilities. This role is a hybrid onsite opportunity located at our AbbVie office in Lake County, IL. Qualifications
Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject. Preferred Education: Relevant advanced degree preferred. Certification a plus. Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership. Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing. Experience developing and implementing successful global regulatory strategies; experience working with Health Authority. 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-term incentive programs. This job is eligible to participate in our 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. Note:
This description may include references to multiple roles or locations; only the stated role and location pertain to the current posting. Seniority level
Director Employment type
Full-time Job function
Legal Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Associate Director, Regulatory Affairs CMC - Hybrid Onsite at AbbVie. This role focuses on small molecule products in development and involves developing CMC regulatory strategies, managing regulatory submissions, and liaising with regulatory agencies to enable first-pass approvals. Base pay range $137,500.00/yr - $261,000.00/yr Responsibilities
Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations; responds to regulatory information requests. Analyses and interprets information impacting regulatory decisions; seeks expert advice and technical support as required for strategies and submissions. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies. Develops strategies for CMC agency meetings, prepares for agency meetings, and manages content of pre-meeting submissions; serves as the point of contact for regulatory agency meetings. Manages products and change control with understanding of regulations and company policies; analyzes and approves manufacturing change requests. Represents CMC regulatory affairs on cross-functional teams; negotiates with and influences team members to maximize chances for first-pass approvals. Stays abreast of regulatory procedures and changes in the regulatory climate; analyzes legislation, regulation and guidance and provides analysis to the organization. Develops, implements, and documents policies and procedures within the regulatory affairs department; leads internal RA CMC initiatives. Represents CMC regulatory affairs on project initiatives with other functional areas to drive cross-functional efficiencies. Trains, develops, and mentors individuals; may include formal supervisory responsibilities. This role is a hybrid onsite opportunity located at our AbbVie office in Lake County, IL. Qualifications
Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject. Preferred Education: Relevant advanced degree preferred. Certification a plus. Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership. Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing. Experience developing and implementing successful global regulatory strategies; experience working with Health Authority. 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-term incentive programs. This job is eligible to participate in our 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. Note:
This description may include references to multiple roles or locations; only the stated role and location pertain to the current posting. Seniority level
Director Employment type
Full-time Job function
Legal Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr