Fully Remote Associate Scientific Director

4 weeks ago

United Kingdom Rho, Inc. Full time
Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.
You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. We are currently hiring an Associate Director, European Regulatory Strategy, to join our team In this role, you will have the opportunity to provide regulatory support to Rho clients and project teams in support of our clients’ interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. To be considered, you will need to have extensive knowledge of European regulatory affairs, and an understanding of the dependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory for integrated development programs across all phases from pre-phase 1 to marketing application. Reporting to the Director, European Regulatory Strategy, you will serve as a regulatory expert, providing full support for Rho’s project teams, including management and oversight of project-specific European regulatory activities, services, and deliverables.
Our Regulatory Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group
As part of Rho’s global Regulatory Strategy & Biometrics team, provides regulatory support for the development programs and regulatory submissions of Rho’s clients, including strategic regulatory consulting, CTA and MAA submissions, regulatory authority interactions, and implementation of European regulatory strategies.
In support of Rho’s clinical trial projects that include sites in Europe, provides regulatory guidance and support for the preparation, compilation, and submission of European CTAs, including development of overall CTA submission strategy, regulatory support for selection of countries and investigational sites, assessment of potential responses from regulatory authorities and ethics committees, preparation of responses to regulatory authorities during CTA review, and maintenance of CTAs.
For Rho’s regulatory projects that include European MAAs, provides regulatory oversight and support for MAA preparation and submission activities as appropriate for the project scope, including conducting gap analysis for MAA submission readiness, developing overall MAA submission strategy, preparing and compiling MAA Module 1, preparing and reviewing Modules 2 Module 3, and assessing potential responses from EMA and other regulatory authorities for MAA submissions.
In collaboration with Rho’s scientific and regulatory experts in the Regulatory Strategy & Submissions team, provides European regulatory support for projects at various phases of development, including conducting gap analyses for European development programs, preparing and reviewing European components of global integrated development programs, developing European regulatory strategy, preparing Pediatric Investigational Plans, and assessing and applying for potential expedited pathways and special designations.
Authors documents for European regulatory submissions, including components of CTAs and MAAs, meeting packages for scientific advice and pre-submission meetings, pediatric investigational plans, requests for orphan designation and expedited pathways, and other relevant regulatory documents, working closely with our clients and Rho’s cross functional colleagues and external consultants as required.
Supports the Director, European Regulatory Strategy with the planning and preparation of European regulatory authority meetings.
Monitors and analyzes appropriate European regulatory agency activities in areas of interest to Rho’s clients, monitors emerging European legislation and guidance, and contributes to ensuring awareness and compliance across Rho’s clinical trial and regulatory strategy/submissions project teams, as appropriate.
Working with the Rho projects teams, proactively identifies risks, critically analyzes problems affecting the programs and supports the development of contingency plans as needed.
Provides effective, accurate and timely communication of key issues and progress to the team and Regulatory Strategy Leadership
Supports business development activities related to Rho’s European regulatory capabilities and services.
Supports the development of commercial proposals that require European regulatory activities and deliverables, including development of budgets.
PhD/PharmD or equivalent demonstration of analytical ability and a minimum of eight (8) years of relevant European regulatory and integrated product development experience
experience with other regulatory authorities such as FDA and Health Canada desired
Broad knowledge of the European regulatory landscape, experience in interpreting European regulations and guidelines, and experience and knowledge in the preparation of major European regulatory submissions and supportive amendments or supplements
Excellent regulatory intuition and project management acumen
Ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, PowerPoint, Word, etc. Ability to travel as needed
Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, and generous paid time off, holidays, parental leave and bereavement leave.
We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.
#LI-Remote
#

  • Fully Remote Associate Scientific Director

    4 weeks ago

    United Kingdom Hyper Recruitment Solutions Full time

    Join a dynamic team in the heart of London, where the fusion of science and innovation meets quality and leadership. An esteemed pharmaceutical company is seeking an Associate Director for Supplier Quality Management (SQM) to steer their SQM strategy and enhance processes, ensuring excellence in global GxP supplier oversight. Your role will be pivotal in...

  • Fully Remote Associate Scientific Director

    4 weeks ago

    United Kingdom Hyper Recruitment Solutions Full time

    Join a dynamic team in the heart of London, where the fusion of science and innovation meets quality and leadership. An esteemed pharmaceutical company is seeking an Associate Director for Supplier Quality Management (SQM) to steer their SQM strategy and enhance processes, ensuring excellence in global GxP supplier oversight. Your role will be pivotal in...

  • Fully Remote Associate Scientific Director

    1 month ago

    United Kingdom Rho, Inc. Full time

    Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe...

  • Fully Remote Associate Scientific Director

    1 month ago

    United Kingdom Rho, Inc. Full time

    Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe...

  • Fully Remote Associate Scientific Director

    4 weeks ago

    United Kingdom Rho, Inc. Full time

    Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe...

  • Fully Remote Associate Scientific Director

    4 weeks ago

    United Kingdom Rho, Inc. Full time

    Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe...

  • Fully Remote Scientific Director

    1 month ago

    United Kingdom Allergan Full time

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to...

  • Fully Remote Scientific Director

    1 month ago

    United Kingdom Allergan Full time

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to...

  • Fully Remote Scientific Director

    3 weeks ago

    United Kingdom Allergan Full time

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to...

  • Fully Remote Scientific Director

    4 weeks ago

    United Kingdom Allergan Full time

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to...

  • Fully Remote Scientific Director

    4 weeks ago

    United Kingdom Allergan Full time

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to...

  • Fully Remote Scientific Director

    1 month ago

    United Kingdom Velsera Inc. Full time

    Territory Business Director (UK, Life Science) page is loaded Territory Business Director (UK, Life Science) Apply locations Remote, Europe time type Full time posted on Posted 2 Days Ago job requisition id JR100191 Welcome to the era of Velsera! We empower researchers, scientists, and clinicians to drive precision R&D, expand access to, and more...

  • Fully Remote Scientific Director

    1 month ago

    United Kingdom Velsera Inc. Full time

    Territory Business Director (UK, Life Science) page is loaded Territory Business Director (UK, Life Science) Apply locations Remote, Europe time type Full time posted on Posted 2 Days Ago job requisition id JR100191 Welcome to the era of Velsera! We empower researchers, scientists, and clinicians to drive precision R&D, expand access to, and more...

  • Fully Remote Scientific Director

    4 weeks ago

    United Kingdom Velsera Inc. Full time

    Territory Business Director (UK, Life Science) page is loaded Territory Business Director (UK, Life Science) Apply locations Remote, Europe time type Full time posted on Posted 2 Days Ago job requisition id JR100191 Welcome to the era of Velsera! We empower researchers, scientists, and clinicians to drive precision R&D, expand access to, and more...

  • Fully Remote Scientific Director

    4 weeks ago

    United Kingdom Velsera Inc. Full time

    Territory Business Director (UK, Life Science) page is loaded Territory Business Director (UK, Life Science) Apply locations Remote, Europe time type Full time posted on Posted 2 Days Ago job requisition id JR100191 Welcome to the era of Velsera! We empower researchers, scientists, and clinicians to drive precision R&D, expand access to, and more...

  • Employment Law Solicitor

    2 weeks ago

    United Kingdom Remote Worker Ltd Full time €60,000

    1 week ago Be among the first 25 applicants An excellent opportunity to join a team of employment lawyers and paralegals supporting a well-known PLC organisation. You will have excellent employment law experience, particularly in tribunal litigation. The role is fully remote and working in an in-house environment. Responsibilities Partner with stakeholders...

  • Director of Strategy

    2 weeks ago

    United Kingdom Warman O'Brien Full time

    Senior Director of Medical Strategy (Cardiovascular) Top 5 CRO – Fully Remote – UK based – Competitive package A global CRO is seeking a Senior Director to join their Cardiovascular unit. As the subject matter expert with extensive experience in clinical research and trials, you will drive the growth of the organization's Cardiovascular portfolio...

  • Director of Strategy

    2 weeks ago

    United Kingdom Warman O'Brien Full time

    Senior Director of Medical Strategy (Cardiovascular) Top 5 CRO – Fully Remote – UK based – Competitive package A global CRO is seeking a Senior Director to join their Cardiovascular unit. As the subject matter expert with extensive experience in clinical research and trials, you will drive the growth of the organization's Cardiovascular portfolio...

  • Scientific Director

    2 weeks ago

    United Kingdom Nordsterne Full time

    Work where you can be your best you. Join Two Labs (part of the Envision Pharma Group) as we continue to grow our business About us Two Labs, founded in 2003, is a leading pharmaceutical services company that partners with pharma/biotech companies. At Two Labs, we understand no two product paths are alike. We deliver integrated and customized commercial...

  • Scientific Director

    2 weeks ago

    United Kingdom Nordsterne Full time

    Work where you can be your best you. Join Two Labs (part of the Envision Pharma Group) as we continue to grow our business About us Two Labs, founded in 2003, is a leading pharmaceutical services company that partners with pharma/biotech companies. At Two Labs, we understand no two product paths are alike. We deliver integrated and customized commercial...