Associate Director, RA CMC

AbbVie; Illinois; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in the United States is seeking an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies for product submissions, including INDs/CTAs and variations, and to serve as a strategic liaison with authorities.

You will collaborate with global teams, manage submissions, influence decisions, and mentor staff while navigating complex regulatory landscapes across multiple programs.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Strong oral and written communication skills.
• Experience developing and implementing global regulatory strategies and working with Health Authorities.

Responsibilities

• Prepares CMC regulatory product strategies and submissions (INDs/CTAs, amendments, variations, annual reports).
• Represents CMC regulatory affairs on cross-functional teams and with regulatory agencies.
• Reviews and revises regulatory submissions to present data and strategy effectively.
• Leads preparation for agency meetings and manages regulatory change control processes.
• Mentors staff and fosters internal RA CMC initiatives.

Skills

Regulatory leadership

Regulatory strategy

Communication skills

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Pharmacology or Engineering

Job 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.

The Associate Director 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. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.

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
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.
• 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. Leads initiatives internal to 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

• 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

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 Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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