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Director Regulatory Affairs
View: 179
Update day: 29-03-2024
Location: Basel Basel-Stadt BS
Category: Legal / Contracts
Industry: Hospitals Health Care
Position: Director
Job type: Full-time
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Job content
Abbott Established Pharmaceuticals Division (EPD) Is Looking For aDirector Regulatory Affairsfor 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.
- 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
- Bachelor Degree in related scientific discipline or
- Advanced degree (MS including MS RA , MEng, Ph.D) in scientific discipline preferred
- 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
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Deadline: 13-05-2024
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