Manager, RA CMC

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.

About the role

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) works with internal and external partners to deliver products to patients. This role prepares CMC regulatory strategies that enable first-pass approvals under limited management supervision, develops and manages content strategy for regulatory submissions, and builds relationships within Regulatory Affairs, Operations, and Research & Development (R&D) organizations.

Responsibilities

• Prepares CMC regulatory product strategies with limited supervision.
• Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements, and variations under limited supervision.
• Analyzes and interprets information that impacts regulatory decisions; seeks expert advice and technical support as required.
• Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies.
• Responds to global regulatory information requests under limited supervision.
• Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages.
• Manages products and change control with an understanding of regulations, agency guidance, and company policies and procedures.
• Analyzes and approves manufacturing change records with limited supervision.
• Represents CMC regulatory affairs on product development, Global Regulatory Product Teams, and Operations Product Teams; negotiates with and influences team members to maximize chances for first-pass approval of regulatory submissions.
• Stays abreast of regulatory procedures and changes in the external regulatory environment.
• Analyzes legislation, regulation, and guidance and provides analysis to the organization.
• Contributes to the creation of white papers and policies to illustrate current regulatory thinking under supervision.
• Participates in initiatives internal to RA CMC.
• May act as a formal or informal mentor to others.

Qualifications

Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.

Preferred Education: Relevant advanced degree preferred. Certification a plus.

Required Experience: 6 years of biopharmaceutical or related industry experience.

Preferred Experience: 6 years of biopharmaceutical RA, R&D, or Operations experience, including 3 years in regulatory affairs. Experience working in a complex and matrix environment.

Skills: Strong oral and written communication skills.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan for eligible employees.
• Eligibility to participate in long-term incentive programs.

Pay

The compensation range for this role is based on the job grade and may vary depending on geographic location. Individual compensation paid within this range will depend on many factors, and we may ultimately pay more or less than the posted range.