Regulatory Affairs Director Respiratory & Vaccine Therapeutic Area, EPD (m/f/d)
Abbott · Netherlands - Weesp ·
- Category
- Legal
JOB DESCRIPTION:
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life. Today, 114,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.
Abbott’s Established Pharmaceuticals Division (EPD) is looking to recruit a
Regulatory Affairs Director Respiratory & Vaccine Therapeutic Area (m/f/d)
Based in Weesp, Netherlands – reporting to the Head of Global Regulatory Development Strategy, EPD
Primary Job Function:
Provide Strategic leadership to EPD (Established Product Division) 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 –Respiratory and Vaccine Therapeutic Area) 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 (EM, LATAM, India)
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.
Serve on expert committees or associations to represent Abbott views externally.
Supervisory/Management Responsibilities:
Direct Reports: 5
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’s degree in related scientific discipline or advanced degree (MS including MS RA, MEng, PhD) in scientific discipline preferred.
Experience:
15+ years of experience in RA, QA, Clinical/Medical Affairs and/or Manufacturing
5+/- years of experience at Leadership level having strong presence in Emerging Markets
Experience in the Respiratory / Vaccine Therapeutic Area
Strong understanding / expertise of local / regional and Global regulatory requirements / pathways and delivery
Ability to lead and drive cross functionally and collaborate cross regionally
Demonstrated success in leading/executing Regulatory across Emerging Markets
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.