Stellenbeschreibung
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
At our Established Pharmaceuticals Division (EPD) we are currently looking to recruit a
that can be based in our Offices in Basel, Switzerland or Maidenhead, UK
Primary Job Function:
Provide Strategic leadership to EPD Global Regulatory teams in developing and executing Regulatory strategies aligned to the business plans of EPD across different products, therapies and geographies
Represent Global RA in the Strategic Need State Teams (a cross functional leadership team consisting members of I&D, Commercial, Manufacturing , and L&A; Therapeutic Area Focus – Cardiometabolic) to proactively develop mid and long-term portfolio strategies, KPIs, and 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, METAP, Russia & CIS) and collaborate with commercial of these regions to ensure alignment of RA strategies to business.
To 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 Commercial heads of each of the business units of EPD in emerging markets
Coordinate and execute strategies related to regulatory intelligence and policy, advocating Abbott positions with Regulatory Agencies and related policy influencer groups.
In collaboration with Development build advocacy positions with scientific / academic institutions to promote Abbott science with key opinion leaders.
Supervisory/Management Responsibilities:
Position Accountability/Scope:
Lead the Cross functional Strategic Portfolio group of EPD
Anticipate, Strategize, Plan in leading regulatory policy and intelligence activity
Support / Drive regulatory shaping initiatives / external engagement aligned with the strategy
Profile requirements
Education:
Bachelor Degree in related scientific discipline or
Advanced degree (MS including MS RA , MEng, Phd) 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
Job-Familie
Regulatory Operations
Division
EPD Established Pharma
Standort
Switzerland > Allschwil : H-127
zusätzliche Standorte
United Kingdom > Maidenhead : Abbott House
Schichtplan
Standard
Reisen
Not specified
Medizinische Kontrolle
Not Applicable
Wichtige Tätigkeitsbereiche
Not Applicable