AbbVie
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
AbbVie, Waltham, Massachusetts, us, 02453
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite) Join to apply for the
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
role at
AbbVie Senior Manager, Regulatory Affairs CMC (Hybrid Onsite) 1 day ago Be among the first 25 applicants Join to apply for the
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
role at
AbbVie Get AI-powered advice on this job and more exclusive features. This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $121,000.00/yr - $230,000.00/yr Company Description
Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.
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, and 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 Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice.
The scope of this role includes biologics programs. Prior work with protein therapeutics, including ADC, and/or cell/gene therapy is particularly beneficial.
Responsibilities
Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information. Analyzes and interprets information that impacts 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. Responds to global regulatory information requests. Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests. Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization. Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC. Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
This is an onsite hybrid opportunity. The preference is for the individual to be based out of AbbVie's Waltham, MA location. However, there is flexibility to be based in Lake County, IL if needed.
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.
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 experience 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 in a complex and matrix environment. Strong oral and written communication skills. Note: Higher education may compensate for years of experience.
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 short-term 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 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.htmlSeniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at AbbVie by 2x Get notified about new Senior Manager Regulatory Affairs jobs in
Waltham, MA . Boston, MA $200,000.00-$230,000.00 3 days ago Boston, MA $172,521.00-$249,862.00 1 month ago Associate Director/Director of Regulatory Affairs Greater Boston $172,521.00-$249,862.00 2 days ago Associate Director/Director, Regulatory AffairsRegulatory Affairs Director, Global Regulatory Strategy Boston, MA $186,232.80-$279,349.19 4 days ago Cambridge, MA $230,000.00-$245,000.00 2 days ago Director, Regulatory Affairs, Regulatory Science & Execution Boston, MA $173,600.80-$260,401.20 2 days ago Boston, MA $230,000.00-$245,000.00 2 days ago Associate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Director, Regulatory Affairs - Specialty MedicineExecutive Director, Regulatory Affairs - Cell MedicineDirector Life Sciences Regulatory Affairs and LabelingExecutive Director, Regulatory Affairs - Cell MedicineSenior Manager/ Associate Director, Medical Operations Waltham, MA $138,400.00-$193,000.00 1 week ago Boston, MA $147,900.00-$221,800.00 2 days ago Sr Manager - Operational Reporting and Analytics Cambridge, MA $138,000.00-$185,000.00 1 week ago Senior Manager, Regulatory Affairs, Operations Cambridge, MA $127,219.00-$190,828.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr Remote working/work at home options are available for this role.
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
role at
AbbVie Senior Manager, Regulatory Affairs CMC (Hybrid Onsite) 1 day ago Be among the first 25 applicants Join to apply for the
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
role at
AbbVie Get AI-powered advice on this job and more exclusive features. This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $121,000.00/yr - $230,000.00/yr Company Description
Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.
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, and 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 Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice.
The scope of this role includes biologics programs. Prior work with protein therapeutics, including ADC, and/or cell/gene therapy is particularly beneficial.
Responsibilities
Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information. Analyzes and interprets information that impacts 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. Responds to global regulatory information requests. Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests. Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization. Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC. Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
This is an onsite hybrid opportunity. The preference is for the individual to be based out of AbbVie's Waltham, MA location. However, there is flexibility to be based in Lake County, IL if needed.
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.
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 experience 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 in a complex and matrix environment. Strong oral and written communication skills. Note: Higher education may compensate for years of experience.
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 short-term 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 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.htmlSeniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at AbbVie by 2x Get notified about new Senior Manager Regulatory Affairs jobs in
Waltham, MA . Boston, MA $200,000.00-$230,000.00 3 days ago Boston, MA $172,521.00-$249,862.00 1 month ago Associate Director/Director of Regulatory Affairs Greater Boston $172,521.00-$249,862.00 2 days ago Associate Director/Director, Regulatory AffairsRegulatory Affairs Director, Global Regulatory Strategy Boston, MA $186,232.80-$279,349.19 4 days ago Cambridge, MA $230,000.00-$245,000.00 2 days ago Director, Regulatory Affairs, Regulatory Science & Execution Boston, MA $173,600.80-$260,401.20 2 days ago Boston, MA $230,000.00-$245,000.00 2 days ago Associate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Director, Regulatory Affairs - Specialty MedicineExecutive Director, Regulatory Affairs - Cell MedicineDirector Life Sciences Regulatory Affairs and LabelingExecutive Director, Regulatory Affairs - Cell MedicineSenior Manager/ Associate Director, Medical Operations Waltham, MA $138,400.00-$193,000.00 1 week ago Boston, MA $147,900.00-$221,800.00 2 days ago Sr Manager - Operational Reporting and Analytics Cambridge, MA $138,000.00-$185,000.00 1 week ago Senior Manager, Regulatory Affairs, Operations Cambridge, MA $127,219.00-$190,828.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr Remote working/work at home options are available for this role.