Date Posted

Company

Position

  Rho is currently looking for a Senior Nonclinical Research Scientist who will provide strategic and tactical leadership to projects and teams by developing viable and long-lasting solutions to cross-program, cross-functional, and organizational issues and initiatives. Responsibilities * Serves as Rho’s nonclinical product development expert, responsible for the full range of nonclinical product development activities and services required to support the integrated product development programs and regulatory submissions of Rho’s clients, including gap analyses, strategic planning, executing and reporting of nonclinical studies, and authorship and review of regulatory submissions * Leads the nonclinical/preclinical and related regulatory components of integrated product development programs * Provides leadership, guidance, and support to a team, program, or project of large scope, as well as to the Program Management discipline within the company * Mentors and advises staff in nonclinical product development 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 identifies risks and critically analyzes problems affecting the programs * Develops contingency plans as needed * Facilitates achievement of strategic goals for a program * Monitors ongoing progress of key nonclinical deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans * Ensures effective, accurate and timely communication of key issues and progress to the team and Sr. Management. (more info at website; click on position title)

JobID: 2019-1456

The Director of Regulatory Operations oversees the technical preparation, submission, and archiving of all regulatory submissions prepared by Rho on behalf of Rho’s clients, and ensures that all submissions to regulatory authorities are produced on time per project timelines and comply with regulatory authority requirements. The Director plays a critical leadership role with oversight of Rho’s publishing and operations personnel, capabilities, systems, and processes, to effectively publish and submit timely, high-quality, compliant regulatory submissions. Responsibilities * Responsible for Rho’s service offerings to clients for electronic submissions to FDA, Health Canada, EMA, and other international regulatory authorities. * Provide full representation for Regulatory Operations in project teams to support submission planning. * Collaborate with teams to plan, create and submit marketing applications (NDA/BLA, NDS, MAA, JNDA, PMA, 510(k), etc), clinical trial applications (IND, CTA/CTX, CTE, etc), and associated amendments, supplements, and variations, in electronic or paper formats. * Manage regulatory operations personnel and systems to ensure submissions are prepared in compliance with regulatory agency requirements and guidelines. * Maintain current knowledge of FDA, Health Canada, EMA, and ICH requirements for regulatory submissions, and ensures that all regulatory submissions comply with those requirements. * Routinely analyze updated submission requirements from regulatory authorities, assess impact on Rho’s publishing and submissions tools/processes, and implement changes and appropriate training if needed. * Serve as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory operations staff and representatives from cross-functional teams. * Conduct budgeting and forecasting for Regulatory Operations activities and deliverables for proposals to clients as well as internal project tracking. * Working with project teams, develop regulatory submission plans for all submissions, using appropriate project management tools and techniques, to ensure proper tracking of all regulatory submission deliverables. * Identify potential risks to submission plans and propose risk mitigation strategies. * Provide recommendations on resource needs for regulatory operations activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor). * Serve as system owner for regulatory publishing tools and systems (eg, eCTD publishing tools, electronic document management system (EDMS), library system, and electronic templates), and ensure that regulatory publishing tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations. Please refer to full job posting for additional information, including required qualifications.

  Work in coordination with cross-functional management as well as Project Team, Project Steering Committee, core team, and stakeholders to achieve overall Labeling that meets MDR (Medical Device Regulation) requirements. Coordinate planning and implementation activities with Manufacturing, Demand Planning, Logistics and Distribution, Commercial Regulatory Affairs and Business Unit representatives. Experienced with project management tools and processes and can manage critical situations and provide professional communication of project status to senior management as well as all team members.

Contact: Todd Stuyvesant; [email protected]; 1-919-241-7204

  Biotech company seeking a Sr Regulatory Affairs Associate/Specialist. Oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.  Provides primary project management support for all regulatory activities in the US. Provides primary support for regulatory submissions in US. Provides technical writing support for pending BLA and MAA submissions. Works with scientists and stakeholders within the organization on the generation of reports and sections of submittals. Participates in scientific discussions associated with pipeline development and eventual regulatory submissions. Provides regulatory support to new indications for current product and new product development. Maintains domain knowledge in regulatory science, policy and currents trends in drug regulations. Generates sections of briefing packages for regulatory meetings communication skills. Previous small team participation and management or leadership. Relevant pharma, biologics or biotech industry experience. Collaborative Proactive, solution-oriented approach to challenges. High degree of flexibility and adaptability In-depth knowledge of GCP, GMP, GLP and GTP US regulations as well as those of other regulatory bodies.

Experience: At least 7 years of Regulatory Affairs experience and at least 3 years of experience as the responsible person for BLA/MAA submissions. Must have had first-hand experience with at least 2 BLAs Strong scientific background and associated technical/scientific writing skills Experience with early phase (pharm/tox studies) and multi-center clinical trials (phase 1 - 3) Experience with biologicals/advanced therapy medicinal products/FDA CBER Office of Cellular, Tissue and Gene Therapies preferred Ability to travel ~25% of the time.

Contact: Nellie Mcgrath; [email protected]; 1-678-654-4738