Skip to main content

This job has expired

You will need to login before you can apply for a job.

Manager, Regulatory Affairs CMC

Employer
AbbVie
Location
Lake County, IL, US
Start date
Jan 8, 2019

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
Send job

Job Details

Key Responsibilities Includes:
  • Identifies and collects data needed and prepares CMC regulatory product strategies under limited supervision. Seeks expert advice and technical support as required for strategies and submissions
  • Prepares regulatory applications, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
  • Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
  • Develops strategies for CMC meetings, manage preparation for agency meetings and manages content of pre-meeting submissions
  • Regularly informs regulatory management of important timely issues
  • Trains, develops and mentors individuals; may include formal supervisory responsibilities
  • Develops and implements policies and procedures within the regulatory affairs department
  • Analyzes legislation, regulation and guidance and provides analysis to the organization
  • 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 to maximize chances for first pass approval or regulatory submissions
  • Supports combination products and medical devices including design control and change management activities

MULTIPLE POSITIONS AVAILABLE

POSITION MAY BE FILLED AT LEVEL COMMENSURATE WITH EXPERIENCE
  • Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
  • Preferred Education: Relevant advanced degree preferred
  • Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management
  • Experience working in a complex and matrix environment
  • Strong communication skills, both oral and written
  • Preferred Experience: 5 years' experience in Discovery, R&D, or Manufacturing. 5 years' experience in Regulatory Affairs (pharmaceutical/medical device/combination product)
  • Note: Higher education may compensate for years of experience

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Company

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
 North Chicago
Illinois
60064
US
Send job

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert