Associate Director, Regulatory Affairs CMC

Abbvie, Inc Waukegan , IL 60079

Posted 2 weeks ago

  • 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

Additional Information

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

  • Travel: Yes, 10 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Regulatory Affairs Registration And Label Management

Abbvie, Inc

Posted 3 days ago

VIEW JOBS 3/22/2019 12:00:00 AM 2019-06-20T00:00 * Serves as subject matter expert (SME) related to Labeling Operations and Labeling Compliance to develop strategies, processes, and reporting tools. * Leads cross functional and cross divisional teams for process improvement initiatives and develops implementation plans and coordination of tasks. Serves as strategic regulatory partner to IT for system initiatives/issues. Leads cross-functional teams to resolve product labeling process and compliance issues. * Provides leadership and technical expertise for the creation, maintenance or management of product labeling in systems (e.g. document management systems, labeling systems, etc.) to meet regulatory requirements. * Drives process improvements within cross-functional teams, including continuous improvement throughout the department by employing quality principles. * Identifies and evaluates industry trends and develops and implements policies, procedures and system improvements. * Maintains an awareness of legislation and assesses its impact on department strategies, systems and processes. * Effectively plans and prioritizes workload, follows up to assure success, and works to bring issues to resolution. May manage staff. * Provides operational metrics. Required Experience: * 8 years in pharmaceutical or industry related experience.Proven 3 years in a leadership role with strong management skills. Demonstrated analytical capabilities * Experience working in a complex and matrix environment.Strong communication skills, both oral and written.Demonstrated ability to lead multi-divisional and multi-functional teams. Preferred Experience: * Experience in project management, Experience/understanding/use of software tools, International Regulatory experience * Proven leadership capabilities in a multi-disciplinary environment4 years' experience managing employees * Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education. Additional Information * Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) * Travel: Yes, 5 % of the Time * Job Type: Experienced * Schedule: Full-time Abbvie, Inc Waukegan IL

Associate Director, Regulatory Affairs CMC

Abbvie, Inc