European Regulatory Strategy Consultant

At Rho, we are truly changing what it means to work with a CRO, and we are quickly expanding our presence in Europe

At Rho, we are currently looking for a European Regulatory Strategy Consultant. In this diverse and exciting role, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. For this role, you will need to have in-depth European regulatory experience and a firm 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. You will serve as Rho's senior European regulatory expert and ensure full support for Rho's project teams, including management and oversight of European regulatory activities, services, and deliverables. As one of the first leaders within Regulatory in the EU, you'll have the opportunity for growth into higher levels of leadership opportunities.

Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest.

Why Rho?

• Regulatory Affairs continues to be a thriving focal point for our business with strong employee tenure and stability.
• We are large enough for strong stability, but small enough for you to have strong visibility and exposure to grow your career
• Support and collaboration is everywhere – from the top down. You have plenty of artillery to be successful here
• It's fun and vibrant – our culture is unbeatable
• Great benefits and time off
• Lastly, we do great work and our studies are properly staffed, that makes for very happy people

These are just some of the reasons Rho has consistently been thought of as one of the CRO industry's best places to work for the past 38 years

By joining Rho, you will have the opportunity to work with some of the most talented minds in the industry to solve complex problems for our clients.

• As part of Rho's global Regulatory Strategy & Biometrics team, serve as the European regulatory expert at Rho, responsible for the full range of European strategic and tactical regulatory activities and services required to support 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.
• As appropriate, ensure alignment of European regulatory activities and deliverables with the overarching global regulatory strategy and integrated development programs for Rho's clients.
• In support of Rho's clinical trial projects that include sites in Europe, lead 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, provide strategic and tactical oversight and management of 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, assessing potential responses from EMA and other regulatory authorities for MAA submissions, identifying and engaging qualified expert reviewers in Europe, and managing the MAA review procedure.
• In collaboration with Rho's scientific and regulatory experts in the Regulatory Strategy & Submissions team, provide European regulatory consulting services 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.
• Author and review 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.
• Serve as a liaison to the European Medicines Agency (EMA) and National Competent Authorities, on behalf of Rho's clients.
• Lead the planning, preparation, and conduct of European regulatory authority meetings, and moderate regulatory authority meetings and leads discussions with regulatory authorities as appropriate.
• Monitor and analyze appropriate European regulatory agency activities in areas of interest to Rho's clients, monitor emerging European legislation and guidance, and contribute to ensuring awareness and compliance across Rho's clinical trial and regulatory strategy/submissions project teams, as appropriate.
• Provide leadership, guidance, and support to a team, program, or project of large scope, as well as to the Program Management discipline within the company
• Mentor and advise staff in areas of expertise by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
• Proactively identify risks and critically analyze problems affecting the programs
• Develop contingency plans as needed
• Facilitate achievement of strategic goals for a program
• Monitor ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans
• Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management
• Manage scope of work, budget, and timelines for external vendors, including consultants, external medical writers, preclinical toxicology houses, and other vendors as appropriate
• Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals
• Serve as a proposal leader for commercial proposals with specific responsibility for the development and articulation of the technical strategy sections of the proposal
• Provide guidance and input to the budgets and business submissions of proposals
• Mentor other technical leads in business development and proposal creation activities

• PhD/PharmD or equivalent demonstration of analytical ability and a minimum of twelve (12) years of relevant European regulatory and integrated product development experience
• Experience with EMA and European national authorities is required; experience with other regulatory authorities such as FDA and Health Canada desired
• Expert knowledge of the European regulatory landscape, direct experience interfacing with European regulatory authorities, 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 written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company
• Proven ability to establish credibility with professionals on program teams
• Excellent regulatory intuition and project management acumen
• Ability to understand and motivate others and build effective teams
• Ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure
• Excellent presentation and critical thinking skills
• 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. in addition to experience working within shared work environments
• Ability to travel as needed

Please submit CVs in English

#LI-Remote

#Biometrics