Oct 6

Job: Associate Director (Japan, Asia) for Pharma Research co. (Illinois)

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Posted originally by Steven Sundstrom to the JETAA Chicago LinkedIn group. Posted by Kim ‘Kay’  Monroe (Miyazaki-shi, 1995 -97). Click here to join the JETwit Jobs Google Group and receive job listings even sooner by email.
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Position: Associate Director, Area & Affiliate, (JAPAC) Japan, Asia Pacific
Posted by: AbbVie
Type: Full-time (some travel)
Location: Abbott Park, Illinois
Salary: N/A
Start Date: N/A

Overview:
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

Primary Function / Primary Goals / Objectives:
Primary contact for Japan and Asia Pacific Region in Regulatory Affairs. Responsible for developing and implementing regulatory strategies for products in assigned therapeutic areas, for filing and MAH approvals in Japan and Asia Pacific Region. in conjunction with Global Regulatory Lead(GRL), Global Regulatory Product Team(GRPT), and affiliate local teams. The Associate Director will ensure application of best practices and compliances on regulatory activities internally and externally for filings and agency interactions.

Major Responsibilities:

  • Develops and implements Japan and Asia-Pacific regulatory strategies with risk assessments for new products and marketed products in the assigned therapeutic area, be aligned with global strategies in GRPT and changing regulatory environment and business needs.
  • Manages preparations and review for submissions, Agency meetings and communications, and assure effective Agency interactions, data presentations and submission dossier. Coordinate internal discussion and review by Affiliate local teams and Global teams.
  • Manages effective interface with local Agencies for key project issues.
  • Proposes new/revised policies and recommends standard interpretation of regulation in Japan and Asia-Pacific area. Ensures application of policies once established.
  • Maintains an awareness of legislation and assesses impact on Abbvie business and Abbvie product development programs.
  • Manages performance of their staff to develop leaders and deliver the objectives of the organization
  • Supervisory / Management Responsibilities:
  • Manages 0-3 regulatory affairs professionals.
  • Lead and facilitate agency meetings and filing activities.
  • Management skills required to coordinate opinions, integrate strategies, reach consensus within Affiliate RA and other global functions.
  • Performance management and mentoring of existing staff members

Qualifications
Education / Experience Required:

  • A Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related life sciences is required. A relevant graduate degree is preferred.
  • A minimum of 8 years’ experience required in pharmaceutical regulatory affairs or R&D in Japan and/or other Asia-Pacifc region. Experience in the US and EU is highly advantageous.
  • Proven skill at developing and implementing successful clinical and regulatory strategies, with preferred experiences of writing CTD and responses for NDA/new indication submissions in Japan or other Asia-Pacific Region.
  • Knowledge and comprehension skills of pharmaceutical regulations in Japan and other Asia-Pacific Region.
  • Experience in working with Health Authority personnel, demonstrated successful negotiation and communication skills.
  • Fluency in English. Fluency in Japanese or other Asian languages will be highly advantageous.

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

Click here to see full description and to apply:  https://abbvie.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=130000031I#!


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