Date Posted

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Position

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

  A well-funded clinical stage biotech is expanding their executive team. Now is an exciting time to get in on the ground floor of this start-up. Due to this continued growth, they are currently seeking a Head of Global RA that enjoys being both strategic and hands-on. Requirements: BS/MS/Ph.D. 15+ years of global regulatory submissions experience which must include BLAs (having both BLA and NDA experience a plus) Direct interaction experience with the FDA Track record of successful submissions (NDA, BLA) Must have some previous experience within smaller clinical stage pharma organizations (having all big pharma experience will not be a fit for their team). Excellent leadership and communication skills Ability to work in a fast-paced environment. Must be able to work from their offices in the Research Triangle Park area (no home based or remote office is available).

JobID: J56000-RALE

Omeros, in beautiful Seattle, Washington is a growing and dynamic organization. We are seeking a Sr. Director, Regulatory Affairs to join our Regulatory Affairs team. In this position, you will be responsible for leading the Regulatory Affairs function. This includes Regulatory CMC, Regulatory Managers, Regulatory Operations, Technical Writing, and Pharmacovigilance. In addition to oversight and management of the Regulatory Affairs function, you will be responsible for developing and implementing the regulatory plan for key programs.

  The QA Associate I will perform a variety of duties in support of the GMP programs at Duke University, including critical review and composition of deviations and investigations, review/revision of SOPs, release of materials, qualification of critical suppliers, review of product release, audit of programs under ORAQ's purview, and quality training. This position will be focused on support of the Molecular Products and Cellular Therapies (MPACT) GMP Facility at Duke University and will consult with manufacturing operations staff, as applicable/requested, to serve as a resource.

JobID: 401522175

 Primary Responsibilities: * Lead efforts for coordinating CMC content for original INDs, IND amendments, IMPDs, for inclusion in Clinical Trial Applications and NDAs * Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, DSURs and background documents for Regulatory Authority meetings * Provides strategic CMC regulatory interpretation and guidance to project teams * Facilitate and deliver the regulatory strategy to support the lifecycle of assets (accountable for execution of CMC aspects). * Manage and contribute to CMC projects, initiatives & actions along with prioritizing assigned workload appropriately. * Manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects. * Serve as CMC representative on a cross-functional project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria. * Manage regulatory issues, maintain submission information in relevant CMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision. * Serve as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects. * Develop relationships with regulatory authorities to improve G1's regulatory success. * May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions. * Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects. * Develop effective relationships across G1, ensuring all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.

  Primary Responsibilities: Reporting to the VP, Global Regulatory Affairs the primary focus of the Associate Director, Regulatory Affairs role will be to provide support for the regulatory affairs department, with a primary focus on clinical development activities such as clinical trial activation and management, IND and CTA submissions/amendments, and health authority interactions. The role will closely interact with multiple functions leading projects and regulatory initiatives, and creating high quality regulatory submissions that support G1*s product development strategy. Key activities include (or may include): * Leading regulatory submission planning and coordination, including the preparation of regulatory submission documents, and reviewing regulatory submissions for completeness and quality in accordance with regulatory agency requirements, standards, and corporate practices * Play a key role in the development of global regulatory strategy regarding overall development plans * Responsible for maintaining active IND/CTAs, including timely coordination of responses to health authority questions/comments * Representing the regulatory affairs function in study teams to provide regulatory support and advice * Interacting with corporate partners, CROs, and vendors regarding various regulatory matters * Providing support for regulatory interactions, including health authority meetings and teleconferences * Ability to troubleshoot situations as needed and understands when problems need to be escalated to the VP, Global Regulatory Affairs.

  The Regulatory Analyst 3 is responsible for the preparation of all internal and external regulatory reports and analysis, inclusive of Florida Public Service Commission (FPSC) and other external regulatory requirements. This position also assists with financial analyses and special projects. The Regulatory Analyst 3 is responsible for developing new programs, rates, and other regulatory strategies.