Vice President, European Regulatory Strategy

Job title:

Vice President, European Regulatory Strategy

Company

Rho

Job description

OverviewJoin 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 a Vice President, European Regulatory Strategy to join our team!The Vice President, European Regulatory Strategy will play a critical role to provide comprehensive European strategic regulatory support to Rho clients and project teams in support of our clients’ interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. This role serves as Rho’s senior European regulatory expert and ensures full support for Rho’s project teams, including management and oversight of Rho’s European regulatory personnel, activities, services, and deliverables. Working closely with the Business Development team, this position also supports sales and marketing activities to expand Rho’s regulatory business in Europe.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

• Serve as the senior line manager for the European regulatory personnel within Rho’s global Regulatory Strategy and Biometrics team, responsible for developing and managing the European regulatory team, as well as fostering a culture of excellence and continuous improvement, and provide strategic guidance and support to team members on complex regulatory issues.
• Interact with senior leadership concerning the strategic and operational direction of the European regulatory team in alignment with company objectives and client needs, including assessments and recommendations of organization and functional areas within the European Regulatory team.
• Serve as the primary European regulatory expert at Rho, providing strategic regulatory consulting and developing European regulatory strategies for Rho’s clients.
• Working closely with Rho’s business development team, participate extensively in sales and marketing activities to expand Rho’s regulatory business in Europe, including the identification and assessment of new sponsors and new opportunities, representing Rho at European conferences and meetings, and conducting capture activities for anticipated proposals.
• Serve as Rho’s European regulatory expert on capabilities calls and bid defense meetings with prospective clients.
• Ensure alignment of European regulatory activities and deliverables with the overarching global regulatory strategy and integrated development programs for Rho’s clients.
• For clients developing products for European markets, assist clients in the development and implementation of comprehensive European regulatory strategies for product development, approval, and lifecycle management, and provide expert advice and guidance on European regulatory requirements and strategies.
• Serve as a European regulatory subject matter expert for the authorship and review of documents for European regulatory submissions.
• Oversee preparation, submission, and management of European regulatory submissions, including Marketing Authorization Applications (MAAs), Pediatric Investigational Plans, requests for Scientific Advice, requests for special designations and expedited pathways, and ensure full regulatory strategic and tactical support to Rho’s Clinical Trial Operations for submission and review of European Clinical Trial Applications (CTAs).
• Serve as the primary point of contact with European regulatory agencies for clients’ projects, and build and maintain strong relationships with key regulatory authorities.
• Develop and implement risk management strategies to address European regulatory challenges and mitigate potential risks.
• Monitor and analyze regulatory trends, changes, and developments in Europe, and disseminate regulatory intelligence to internal stakeholders and clients, providing strategic recommendations based on the evolving regulatory landscape.

Qualifications

• PhD/PharmD or equivalent demonstration of analytical ability and a minimum of fifteen (15) years of relevant European regulatory experience and at least 7 years in a management and/or leadership role
• Experience with EMA and European national authorities is required
• 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
• Experience supporting sales and marketing activities for regulatory services, including authorship of regulatory-focused material, review of proposals, and participation in capabilities meetings and bid defense meetings.
• Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company; fluent in both English and local language
• 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 your CV in English#LI-Remote

Expected salary

Location

United Kingdom

Job date

Sat, 13 Jul 2024 04:31:48 GMT

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