Abbott Established Pharmaceuticals Division (EPD) is looking for a:

Director Regulatory AffairsWomen's Health

for our global EPD Headquarter based in Allschwil/Basel, Switzerland.

In this challenging Role you:

• Provide Strategic leadership for EPD Global Regulatory teams, Innovation & Developmennt (I&D) and wider EPD business in developing and executing Regulatory strategies aligned to the business plans of EPD across different products, therapies and geographies
• Lead cross functional team consisting members of I&D, Marketing/Commercial, Manufacturing, Finance and Licencing & Acquisition to proactively develop future strategies, KPIs, improve innovation speed to market.
• Provide Strategic Regulatory guidance, leadership and expertise to Regional Heads of Regulatory across all emerging markets (LATAM, India, EM - APAC, MEP, Africa, Russia & CIS) and collaborate with global (and regional) commercial to ensure alignment of RA strategies to business.
• Provide optimized regulatory strategies in compliance with national and international standards, deliver quality and timely support for submissions / approvals, foster interactive and positive relationship with regulatory agencies / Key opinion leaders and provide regulatory strategies to ensure maximum product potential.

Core Job Responsibilities:

• Combined knowledge of scientific, regulatory and business issues to develop products to meet required global, regional and local regulatory requirements.
• Develop a comprehensive regulatory external engagements stakeholder management strategy with leadership of Regional RA and other key stakeholders of each of the business units of EPD in emerging markets
• Coordinate and execute strategies related to regulatory intelligence and policy, advocating Abbot’s position with Regulatory Agencies and related policy influencer groups.
• In collaboration with Development build advocacy positions with scientific / academic institutions and / or Regulatory Agencies to promote Abbott science with key opinion leaders.
• Serve on expert committees or associations to represent Abbott views externally, as required.
• Lead a Team of up to 7 Direct Reports

Education:

• Bachelor Degree in related scientific discipline or
• Advanced degree (MS including MS RA , MEng, Ph.D) in scientific discipline preferred

Experience:

• Demonstrated success in leading/executing Regulatory across Emerging markets
• Strong understanding / expertise of local / regional and Global regulatory requirements / pathways and delivery
• Ability to lead and drive cross functional and cross regional collaboration
• 5+/- years of experience at Leadership level having strong presence in Emerging markets
• 10+ years of experience in RA, QA, Clinical/Medical Affairs and/or Manufacturing

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf.

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