Associate Director, Regulatory Affairs - Clinical Trials (FSP Strategy & Business Development)
Thermo Fisher Scientific
Thermo Fisher Scientific seeks an Associate Director of Regulatory Affairs for clinical trials to ensure global regulatory compliance and support product lifecycle management. The role involves interpreting regulations, developing regulatory strategies, and collaborating across functions to bring innovative products to market while maintaining patient safety.
Responsibilities
- Interpret and disseminate global regulations, guidelines, and industry developments to stakeholders
- Develop and implement regulatory strategies aligned with business objectives and compliance needs
- Evaluate regulatory impact on products and provide strategic recommendations
- Support regulatory submissions and maintain compliance throughout product lifecycles
- Collaborate with cross-functional teams and regulatory authorities on submissions and policy matters
Requirements
- Advanced degree plus 6 years regulatory affairs experience, or bachelor's degree plus 8 years
- Background in science, engineering, pharmacy, or related field
- Deep knowledge of global regulatory requirements and emerging technologies
- Proven experience with regulatory submissions and filings to global authorities
- Experience managing regulatory information systems and related software tools
- Post-market surveillance and vigilance activity background
- Expert communication skills for complex regulatory concepts to diverse audiences
Vaga publicada 17 dias atrás
Empregos semelhantes que podem ser interessantes para vocêCom base na vaga Associate Director, Regulatory Affairs - Clinical Trials (FSP Strategy & Business Development) em Home office
- ...Amgen seeks a Clinical Scientist Director to lead late-phase oncology trial execution, translating clinical strategy into actionable oversight of protocol... ..., data quality, and regulatory alignment. The role requires... ...clinical drug development experience preferred ~...
- ...is a specialist clinical research organization... ...the most complex trials, the studies... ...through early phase development, so they reach... ...competitive and flexible strategies for potential... ...with Business Development for assigned... ...Management, Statistics, Regulatory and Safety as per...
- ...Medical Director position supporting clinical trials and pharmacovigilance within the neurology therapeutic area... ...medical leadership, protocol development, real-time study monitoring, and... ...GCP guidelines, and all relevant regulatory requirements Requirements MD...
- ...experience as a Physical Therapist, a role as a Business Development Manager at VALD could be the change you... ...(both in-person and teleconferences) in clinical, performance, and tactical settings. You'll set up and oversee product trials, nurture new leads and look for new...Trabalho remoto
$50,000 a $80,000 por año
...applications and next steps. Our partner is looking for an Operations Strategy Associate based in Portugal. This is a high-impact, generalist... ...problem-solvers who enjoy tackling a wide range of business challenges. You’ll analyze data, improve processes, build scalable...- ...Join Us as a Clinical Research Associate (Level II) and above... ...are hiring in our FSP and FSO teams!... ...spanning 2,700 clinical trials across 100+... ...assess protocol and regulatory compliance and... ...ensure that the trial is conducted in accordance... ...using approved business writing standards...Trabalho remoto
- ...Fisher Scientific seeks a Clinical Research Associate Level II/Senior to... ...sites across clinical trials. The role involves assessing... ..., and ensuring regulatory adherence to support trial integrity and subject safety... ...experience or PPD Drug Development Fellowship completion...
- ...Thermo Fisher Scientific seeks a Clinical Research Associate (Level II+) for remote work in Portugal... ...protocol compliance, and manage clinical trial documentation. The role involves... ...monitoring visits to assess protocol and regulatory compliance Review source data...
- ...keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the... ...time with good quality and in compliance with the applicable regulatory requirements. - Support project teams as PV expert on all...
- ...Alphanumeric is hiring a SERM Medical Director (Remote, 1-Year Contract... ...management of products in clinical development and post-marketing settings... ...safety issues, support regulatory interactions, and... ...work within U.S. and/or U.K. business time zones. Key Responsibilities...Trabalho remoto
- ...every decision, from early development through to post-marketing surveillance... ...to, and management of, the Associate Directors, ICSR. Other... ...experience in post marketing and clinical processing and staff... ...applicable - Supporting the Business/Commercial team during development...
- ...Are you passionate about building and growing relationships within the iGaming ecosystem? At Scaleo, we're looking for a Business Development - Lead Generation Manager to help expand our presence across Europe, build meaningful industry partnerships, and represent...Trabalho remoto
- ...behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Project Manager – Strategy & Impact Business Enablement based in Portugal. This is an exciting opportunity for an experienced project manager to lead strategic initiatives...
- ...This is the general track for Engineering Director at Canonical, apply here if you are... ...reliable and more secure for deployment and development. We strive to be the provider of ‘most... ...(and more often for graduates and associates) to ensure we recognise outstanding performance...
- ...looking for a Senior Director, Product (Employer of... ...will own the vision, strategy, and execution for a critical... ...You will turn complex regulatory and operational... ...strategy and broader business outcomes. You will lead... ...first approach to product development, using AI to improve...
- ...is looking for a Technical Director, Applied AI based in Portugal... ...emerging AI technologies to game development, creative production, and... ...technical art, and internal business workflows. - Build proof-of-... ...- Help shape the long-term strategy and capabilities around...
- ...are committed to supporting your development within the company. Our business principles include: Integrity, Health... ...market, client, competitor and regulatory insights into scalable service propositions... ...aligned with the Medical Devices strategy and growth priorities. - Lead the...
- ...close to 500 million people in developing countries. Political Affairs Internship: The role focuses on making poverty a focus of U.S.... .../Constituency. Representing The Borgen Project at various business, political and community events. Assisting with fundraising....Trabalho remoto
- ...full-cycle game art outsourcing and co-development company with a global production network... .... We are looking for an Art Director to own the creative direction of cosmetic... ...You have shipped as an Art Director, Associate AD, or principal/lead artist on AAA titles...Trabalho remoto
- ...Our partner is looking for a Director of Professional Services,... ...broader Customer Experience strategy and collaborate closely with... ...developing evidence of customer and business impact. - Collaborate with... ...implementations, or custom development. - Proven experience...
- ...beyond through research, development and delivery of life-... ...therapies. With clinical trials conducted in 100+ countries... ...clinical trial services. Your determination... ...The (Senior) Medical Director will provide medical... ...Shown understanding of regulatory guidelines for...Trabalho remoto
- ...throughout Eastern Europe. We are currently looking for an Associate Producer to join our core publishing team, who will be... ...responsibilities)? ~ Work closely with the Executive Producer to help our development teams bring their games to market at the desired quality,...Trabalho remoto
- *Resume MUST be in English Location: EU Role: Sales Development Representative (EU) Department: Sales Department About Respond... ...in Hong Kong in early 2017, respond.io ( is an AI-powered business messaging platform that helps companies manage customer conversations...Trabalho remoto
- ...time location platform for a new generation of location-aware businesses. Mapbox is the only platform that equips organizations with... ...value engineers who can thoughtfully integrate AI into design, development, and decision-making. Our interview process will include...
- ...platform, helping 20 million businesses and individuals access... ...data and analytics roadmap and strategy - Team Building & Management... ...business analysis and model development and productionisation. Drive... ...campaign performance and refine strategies - Define and track growth...
- ...all applications and next steps. Our partner is looking for a Business Consultant based in Portugal. We are seeking an experienced Business... ...on engineering efficiency and the management of product development lifecycles. Accountabilities: - Collaborate with R&D, engineering...
- ...manages all applications and next steps. Our partner is looking for a Admin/Business Support based in Portugal. This is a part-time remote opportunity focused on supporting business development through structured outbound outreach and partnership appointment setting. You...
- ...next steps. Our partner is looking for a Marketing Analyst, New Business and M&A based in Portugal. As a Marketing Analyst, you will... ...advertising data into actionable insights that guide acquisition strategies, budget allocation, and business growth. Working across...
- Hogan Product Development: Defines and documents business requirements and solution designs. Creates and executes test cases. Provides support to developers. Participates in technical reviews. Responsibilities Development, maintenance and support...Trabalho remoto
- ...customer-facing and internal platforms. This exciting role allows you to impact daily operations, traveler experiences, and product development directly. NOTE: Candidates must reside in Portugal for consideration, or willing to relocate. Please submit all applications in...
Deseja receber mais vagas?
Assine e receba vagas semelhantes a Associate Director, Regulatory Affairs - Clinical Trials (FSP Strategy & Business Development). Seja o primeiro a se candidatar!
