Director, Regulatory Affairs - Europe
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Roskilde
Director, Regulatory Affairs
Summary:
Take part of the European Regulatory Affairs matrix growth and maximize Regulatory Compliance & Services capabilities within our network covering Drug Substance (chemical & biological) and Drug Product (clinical & commercial)
Contract Manufacturing and Development (CDMO) Services, including:
Key Requirements:
Regulatory Intelligence
Monitor, anticipate, pre-evaluate and communicate on major pharmaceutical regulations impacting the Drug Product business (sterile & non sterile dosage forms):
Regulatory Compliance Activities
Bring regulatory systems to the next level: sponsor best practices initiatives for harmonization & optimization, coordinate programs at community level
Regulatory Services Offer
Raise the bar on regulatory services offering and associated revenue generation:
Education:
Advanced Degree in European Life Science (ex: Pharmacy, Chemistry, Microbiology)
Experience:
Extensive experience of directly relevant pharmaceutical regulatory affairs, CTD Quality/CMC, and cGMP manufacturing operational exposure. Intimate knowledge of European regulatory environment. Proven thought leadership within professional communities such as TOPRA, PDA. Significant and demonstrated ability to successfully mentor high performing teams at a regional level within a multicultural/multidisciplinary framework. Must be able to sustain travel schedule of approximately 35% within Europe.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .
Summary:
Take part of the European Regulatory Affairs matrix growth and maximize Regulatory Compliance & Services capabilities within our network covering Drug Substance (chemical & biological) and Drug Product (clinical & commercial)
Contract Manufacturing and Development (CDMO) Services, including:
- Fostering EU regulations knowledge within the Global Q/RA network
- Contributing to site & product compliance to regulatory standards
- Interacting with key Customers & Regulatory Agencies to develop and execute to regulatory strategies
Key Requirements:
Regulatory Intelligence
Monitor, anticipate, pre-evaluate and communicate on major pharmaceutical regulations impacting the Drug Product business (sterile & non sterile dosage forms):
- Collaborate with key industry stakeholders as to input on new regulatory trends and provide SME consultation to organization
- Enhance internal regulatory knowledge by developing appropriate forums & tangible trainings
Regulatory Compliance Activities
Bring regulatory systems to the next level: sponsor best practices initiatives for harmonization & optimization, coordinate programs at community level
- Site compliance: oversee domestic licenses, foreign accreditations, master documents conformity and support regulatory inspections & key Customer audits
- Product compliance: leverage regulatory systems use and contribute to critical quality issue resolution
Regulatory Services Offer
Raise the bar on regulatory services offering and associated revenue generation:
- Identify & develop areas of growth upon creative business models revisit/setting
- Influence key European projects within NIP or technology transfers or new strategic Customers
- Lead within major regulatory quotations issuance
- Deliver ad hoc expertise on registration files relevant to MAA-variations or IND-NDA- BLA-PAS-CBE/30-AR and assess overall regulatory acceptance/risk
Education:
Advanced Degree in European Life Science (ex: Pharmacy, Chemistry, Microbiology)
Experience:
Extensive experience of directly relevant pharmaceutical regulatory affairs, CTD Quality/CMC, and cGMP manufacturing operational exposure. Intimate knowledge of European regulatory environment. Proven thought leadership within professional communities such as TOPRA, PDA. Significant and demonstrated ability to successfully mentor high performing teams at a regional level within a multicultural/multidisciplinary framework. Must be able to sustain travel schedule of approximately 35% within Europe.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Roskilde.
Jobbet er oprettet på vores service den 1.4.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Roskilde
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Statistik over udbudte jobs som apotekere i Roskilde
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Statistik over udbudte apotekere i Roskilde over tid
| Dato | Alle jobs som apotekere |
|---|---|
| 12. oktober 2024 | 1 |
| 11. oktober 2024 | 1 |
| 10. oktober 2024 | 1 |