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Associate Director, Regulatory Affairs CMC

Employer
AbbVie
Location
Lake County, IL, US
Start date
Mar 25, 2019

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

  • Prepares CMC regulatory product strategies. Seeks expert advice and technical support as required for strategies and submissions
  • Manages the preparation of CMC submissions. Prepares and manages regulatory applications, including new applications and amendments, renewals annual reports, supplements and variations
  • Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
  • Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
  • Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of briefing documents
  • 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, provides analysis to the organization
  • Support combination products and medical devices including design control and change management activities. Provides regulatory guidance and support for risk management and human factors engineering topics for drug, biologic, device and combination products

  • Required Education: Bachelor's Degree in Pharmacy, Chemistry, Biology or Pharmacology or related subject
  • Preferred Education: Relevant advanced degree preferred
  • Required Experience: 8 years pharmaceutical or industry related experience. Proven 3+ years in a leadership role with strong management skills
  • Experience working in a complex and matrix environment. Strong communication skills, both oral and written
  • Preferred Experience: 5 years in regulatory affairs. 10 years pharmaceutical experience (medical device/combination product). 5 years in Discovery, R&D, or Manufacturing
  • Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority
  • 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
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