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REQUIRED DEGREE/EDUCATION/CERTIFICATION: Must be Information Assurance Workforce (IAWF) Information Assurance Management level II (IAM II) certified with at least one (1) baseline certification: CAP; CASP+ CE; CISM; CISSP (or Associate); GSLC; CCISO; or HCISPP REQUIRED SKILLS AND EXPERIENCE: At least 5 years of management experience (preferrably in IA technology or related area.
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The ideal Seizure Specialist will bring knowledge and expertise in the areas of blockchain technology, crypto wallets, virtual asset service providers (VASPs), open-source intelligence (OSINT), dark web, digital forensics, software development, custody of evidence, and asset forfeiture.
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Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. Integrate strategic regulatory & drug development support services into emerging biopharmaceutical company clinical trial offerings.
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Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
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Support the innovative development of compounds to maximize technical, regulatory, and commercial success, including contribution to the development of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as appropriate.
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In this role, you will provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology.
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Strategic regulatory experience in novel oncology investigational product development to registration including interactions with US and European regulatory authorities. Senior Director, Regulatory Affairs - Permanent - Remote.
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Lead assessments of risk and probability of regulatory success and development of mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritization exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.
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Typically requires 15-20+ years relevant clinical research and/or regulatory experience with multi-regional and global focus including significant experience in senior strategic role, including specific oncology investigational product experience.
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Strategic leadership of the development of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), special designations (orphan drugs, pediatrics plans, "fast-track. Interface with clients in collaboration with existing Therapeutic Science & Strategy Unit Centres of Excellence to provide strategic advice and incorporate regulatory guidance.
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In addition you will provide strategic regulatory advice towards efficient clinical development and navigation of US & European regulatory frameworks. Relevant science degree & post graduate specialization or equivalent experience in medicinal product development and regulatory strategy.
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This is a permanent role with the opportunity to work remotely. Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct.
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If you are having difficulty in applying or if you have any questions, please contact. Prior regulatory authority experience desirable. Proclinical Staffing is an equal opportunity employer.
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If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or n.walker@proclinical.com. Prior regulatory authority experience desirable.
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If you are having difficulty in applying or if you have any questions, please contact. Proclinical Staffing is an equal opportunity employer.
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