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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, YouTube and LinkedIn.

Senior Manager RA, Global Reg Strategy US & Canada (REMOTE)

North Chicago, Illinois Req ID 2205191 Category Research and Development Division AbbVie

About AbbVie
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 TwitterFacebookInstagramYouTube and LinkedIn.

  • Makes decisions and plans for work activity (work flow, assignments) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Operates independently, with recognition of when to consult departmental senior
  • Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross-business opportunities. Uses knowledge of global marketplace, technology and business levels effectively
  • In absence of Director, is responsible for day-to-day operations, and departmental initiatives, which have significant impact on both internal and external customers
  • Represents Area & Affiliate on Global Regulatory Product Team (GRPT) and asset teams as appropriate. Advises on regional specific requirements and provides strategic input
  • Serves as Health Authority liaison and interfaces with Health Authority for meetings, etc. Coordinates preparation of Health Authority meeting briefing packages
  • Solid understanding of regulations and guidance of regulatory authorities, political and legal climate and industry practices to assist in meeting organizational goals. Possesses and leverages broad industry knowledge. Coordinates and prepares submissions in line with Health Authority regulatory requirements and guidelines
  • Manages interface with health authority for key projects/issues, including direct negotiation with review division personnel. Coordinates and prepares submissions in line with health authority regulatory requirements and guidelines
  • Manages the preparation and review of regulatory submissions to assure effective presentation of data, complete and timely response to health authority during application review, and quality consistent with health authority regulatory requirements and guidelines
Qualifications:
  • Bachelor’s or advanced degree in pharmacy, biology, chemistry, pharmacology or related life sciences is required
  • At least 5 years of experience required in Regulatory, R&D, or related area with minimum of 3 years of experience preferred in pharmaceutical regulatory activities
  • Experience interfacing with government regulatory agencies and proven skill at implementing successful global regulatory strategies.
  • Demonstrated success in negotiation skills and strategic thinking. Strong communication skills, both oral and written
  • Experience working in a complex and matrix environment is required.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: No
Job Type: Experienced
Schedule: Full-time
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