Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

AbbVie Inc.; Chicago (IL); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Hybrid work schedule

Medical/dental/vision insurance

401(k) with company match

Job summary

AbbVie Inc. is seeking a Senior Manager Regulatory Affairs, CMC to lead regulatory strategies for biologics products and manage INDs/CTAs, amendments, and variations.

You will collaborate with product development, R&D, Operations, and Global Regulatory teams to deliver timely approvals. The role requires management of submissions, change control, and agency meetings, with a hybrid schedule (3 days in office, 2 days remote) at the Waltham, MA and Lake County, IL headquarters.

Qualifications

• Bachelor's degree in pharmacy, chemistry, biology or pharmacology, engineering or related subject. Advanced degree preferred. Certification a plus.
• 8 years’ pharmaceutical experience. Preferred 10 years including regulatory affairs or 5+ 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.

Responsibilities

• Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations.
• Analyzes and interprets information impacting regulatory decisions; seeks expert advice as required.
• 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 and manages content for pre-meeting submissions.
• Manages products and change control, analyzes and approves manufacturing change requests.
• Represents CMC regulatory affairs on cross-functional teams to maximize chances for first pass approval.
• Stays abreast of regulatory procedures and changes; analyzes legislation and guidance.
• Develops, implements, and documents RA CMC policies and participates in internal RA initiatives.
• Represents CMC on project initiatives to drive efficiencies across the company.
• Works a hybrid schedule (3 days in office; 2 days remote) from Waltham, MA & Lake County, IL.

Skills

Regulatory strategy development

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in pharmacy/chemistry/biology/pharmacology/engineering

Job description

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 Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. 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.

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 role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & 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 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

• 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 employer 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