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- ...Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP). Requirements: ~ BS + in pharmacology, toxicology, biology or chemistry, or related...SuggestedRemote jobFull-time
- ...experience in project or programme management, preferably within R&D, IT&D or commercial operations within a regulated environment (e.g. FDA, EMA). Understanding of GxP standards, validation, data integrity principles, with experience working across Regulatory, R&D, and Supply...Suggested
- ...understand English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take...SuggestedFull-timeRemoteWork from home
- ..., regulatory compliance, or project management valued Expertise in CMC strategy, process validation, and regulatory compliance (FDA/EMA) Strong understanding of GMP, GLP, and quality systems Experience in project management and cross-functional team leadership Experience...SuggestedMonday to Friday
€70k - €85k per annum
...to increase IoT penetration for all pump products in our targeted industries, with a strong emphasis on Digital Water products in the EMA region. Location of this role is highly flexible across the UK and Europe. The successful candidate can be based from home, travelling...SuggestedLong-term contractPermanentOn-siteWork from homeFlexible hours- ...Global Regulatory Lead and cross-functional team to lead the EU regulatory strategy and facilitate submission of data packages to the EMA. The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development,...Suggested
- ...Affairs, Public Affairs, Legal and Compliance to deliver integrated affiliate support. Support the Joint Clinical Assessment process for EMA submissions. Ensure that all activities and materials comply with applicable laws, regulations, industry codes, and corporate...SuggestedFull-timeHybrid workingOn-site
£87.62k per annum
...Overview West Atlantic UK is seeking experienced Boeing 737 type rated Captains to join its growing operation at East Midlands Airport (EMA), on a fixed 7 days on / 7 days off roster. As a B737 Captain you will be responsible for the safe and efficient operation of the...SuggestedFull-timePart-timeNight shift- ...therapeutic programs Demonstrated people and project management leadership of global regulatory teams Established relationships with FDA, EMA, and other major health authorities Budget management experience of $10M or greater Track record in regulatory approvals at...SuggestedLong-term contract
- ...briefing packages and CTD Module 2 summaries and overviews, supporting regulatory interactions and maintaining awareness of evolving FDA, EMA and ICH guidance. Collaborate with Product Development (CMC) to coordinate test article supply and formulation, and work across...SuggestedFull-timeInterimHybrid workingOn-site
- ...internal and external networks on regulatory science questions. Desirable Skills/Experience: Experience with FDA advisory committee, EMA oral explanation or equivalent major market advisory preparations. Experience shaping the future regulatory framework through active...SuggestedLong-term contractOn-siteFlexible hours
- ...events, from first response to resolution and post-incident review. Represent Payhawk at the monthly Electronic Money Association (EMA) meetings, bringing PFSL’s issues and views. Work with the wider leadership team on provider relationships (card scheme, transactional...SuggestedFull-timeOn-site
- ...interpreting and summarizing complex clinical trial data and statistical analyses Strong knowledge of regulatory requirements (ICH-GCP, FDA, EMA) and clinical document submission Ability to manage multiple projects simultaneously in deadline-driven environments Excellent...Suggested
- ...Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take...SuggestedFull-time
- ...analyses, with excellent writing, editing, and proofreading skills ~ Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory...SuggestedFull-time
- ...data, notably Germany (IQWiG/G-BA), France (HAS), and the UK (NICE Evidence Standards Framework / DSU Technical Support Documents). EMA: Reflection papers and guidelines on the use of PRO measures in oncology and other therapeutic areas. FDA: Relevant statistical and...Full-timeHybrid working
- ...interacting with global Regulatory Bodies Solid understanding and application of CMC related regulatory guidances (e.g., ICH, FDA, EMA, MHRA) Desirable Skills/Experience: Post-graduate qualification Advanced degree in related field or equivalent experience preferred...On-siteImmediate startFlexible hours
- ...will: Define and drive EU regulatory strategy across development, registration, and lifecycle management Lead negotiations with the EMA and other relevant Health Authorities, translating BMS strategy into real outcomes Build integrated submission plans and translate...Full-timeHybrid workingRemote
- ...review clinical pharmacology regulatory content to support timely approvals and optimal labelling. Maintain up to date knowledge of FDA, EMA, CDE, PMDA and ICH expectations and embed regulatory considerations and best practices into study design and MIDD strategies. Capture...Full-timeHybrid workingRelocation
$212k - $318k per annum
...Serve as the PCO lead across regulatory milestones, including briefing document authoring, Type C meetings, FDA PFDD consultations, and EMA scientific advice procedures. Leverage deep operational knowledge of FDA PFDD Guidances (1–4), FDA 2009 PRO Guidance, and EMA...Long-term contractFull-timeRelief staffRemote- ...contact for assigned therapeutic areas; manage end-to-end disclosure processes Govern Freedom of Information requests under US FOIA and EMA Policy 0043; ensure timely, compliant responses Oversee external vendors supporting transparency, lay summaries, and redaction...
- ...Strategy to lead European regulatory affairs for the Immunology & Cardiovascular portfolio. The role encompasses strategy development, EMA negotiations, submission planning, and lifecycle management across early development through registration. Responsibilities Define...
- ...continuous professional development Preferred Qualifications: • Proven ability to manage multiple protocols • Familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus • Experience with all aspects of the...Full-time
- ...efficient operation of the airside, landside, and terminal environments while ensuring a high standard of customer service is delivered by EMA colleagues and business partners. This is a highly visible operational leadership role with overall safety coordination...Long-term contractPermanentFull-timeImmediate startFlexible hoursShift workNight shift
- ...and communication skills. Familiarity with current ISO 9001 and ISO 27001 standards preferred. Familiarity with 21 CFR Part 11, EMA, MHRA, and GCP requirements. Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process...Remote jobFull-time
- ...Manual of Style. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take...Full-time
- ...-solving skills Excellence in written and verbal communication Ability to interact effectively with regulatory authorities (FDA, EMA) Experience in CRO environment and vendor management preferred Knowledge of auto-immune and/or oncology therapeutic areas beneficial...Full-timeOn-siteMonday to Friday
- ...A Career with Purpose Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world’s leading pharma and biotech...Vacation SchemeHybrid workingFlexible hours
- ...role requires extensive experience leading European regulatory programs and managing interactions with health authorities, including the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other applicable regulatory agencies. In partnership with cross-functional...Full-time
- ...reporting; support data monitoring committees. Contribute to publications and congress presentations, maintain awareness of evolving FDA, EMA and ICH guidance, and drive the development and implementation of clinical development procedures and standards. Contribute to...Full-timeHybrid workingOn-site