Associate Director, European Regulatory Strategy
3 weeks ago
Overview
Join us in redefining what it means to work for a CRO. 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.
At Rho, we’re committed to you just as you’re committed to us. 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. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.
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
Responsibilities- 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.
- Supports achievement of strategic goals for a program
- 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 EMA and European national authorities is required; 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 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
A few more things to know about us:
Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, and generous paid time off, holidays, parental leave and bereavement leave.
Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.
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