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UPCOMING FALL EVENTS

  • Oct 24  – David Shoemaker, SVP, R&D at Rho, Inc 
  • Nov 07  Roundtable Event at Friday Center
  • Dec 12 – Sathya Ganesan, Associate Director, Regulatory Affairs, G1 Therapeutics

  

 

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Job Postings

 

Date Posted

Company

Position

  10/16/2019  Monarch Medical Technologies Sr. Regulatory/Compliance Specialist-FDA med. dev.
  Job Description: Looking for an independent thinker with a ¿can-do¿ attitude that can skillfully leverage regulatory expertise to improve efficiencies and compliance across our organization. The qualified individual must have experience with medical devices, preferably software devices. the ideal candidate will have advanced knowledge and understanding of quality control, risk management and product life cycle requirements as prescribed by the U.S. FDA, E.U. CE and ISO.
  10/16/2019 Ucb Regulatory Scientist
Job Description: Prepare and deliver regulatory operational plans for assigned projects/products within a specific region. Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets. Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives. MAJOR ACCOUNTABILITIES ¿ Support the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional/local country regulations. ¿ Lead the planning, preparation and delivery of both simple and complex submissions throughout the product¿s life cycle from either a global and/or regional perspective. ¿ Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice ¿ Identify potential regulatory risks to the operational plan, and propose options to mitigate risks. ¿ Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents ¿ Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL. ¿ Maintain awareness of competitors¿ activities and share potential impact these activities may have on the product development program ¿ Delivers project assignments supporting the business e.g. representation on functional workstreams ¿ Ensure that appropriate, up-to-date records are maintained for compliance ¿ Assist in development of regulatory standards and SOPs ¿ Provide input into Regulatory Strategy Plans and project budget as delegated by GRL ¿ Assist in due diligence activities for in-licensing opportunities Bachelor's degree plus 5+ years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation COMPETENCIES ¿ Build effective partnerships ¿ identifies opportunities and takes actions to build effective relationships within team and with other areas ¿ Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions ¿ Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person. Works effectively in ambiguous situations. ¿ Communication skills ¿ knows when and how to communicate, using strong interpersonal skills and written communications when appropriate ¿ Results focused ¿ ability to overcome obstacles and achieve key outcomes ¿ Analytical ¿ logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions ¿ Organizational Skills ¿ Integrity ¿ overriding commitment to integrity and high standards in self and other To apply please go to www.ucb.com/careers
  09/23/2019 United Therapeutics Corporation Regulatory Affairs Associate/Senior Associate

  United Therapeutics is seeking a highly motivated individual for the Regulatory Affairs Associate/Senior Regulatory Affairs Associate role to assist with the global regulatory activities for PAH therapies. This position will prepare and maintain new and existing regulatory applications, including investigational and marketing applications (INDs, NDAs, etc.), amendments, supplements, and other submissions in compliance with health authority regulations, interact with cross-functional teams, and contribute to regulatory strategy.

JobID: R01599

 
  08/19/2019 Precision Biosciences Manager Regulatory Affairs
  The Manager, Regulatory Affairs will be a key member of the Development organization and interface with the Cell and Gene Therapy project teams to manage regulatory aspects of projects related to clinical trials, health authority interactions and product approvals. The Manager, Regulatory Affairs works with medical/technical writing and Quality personnel to ensure compliance of submissions and programs with US, EU, and ICH requirements.
 
  08/12/2019 Fpc Of Raleigh Associate Director of Regulatory Affairs
My client, a well-funded, RTP area clinical stage pharma with multiple drug products in their pipeline, with whom I have placed candidates previously is continuing to expand their team - this Senior Manager/Associate Director of Regulatory Affairs role is a newly created position due to their continued expansion. Now is an exciting time to join their growing Regulatory Affairs team. This role is a hands-on role (no direct reports) and will be expected to support regulatory affairs from IND to NDA stage. Local RTP candidates only. Requirements - BS/MS in a scientific area is strongly preferred RAC certification preferred 5+ years of regulatory affairs experience required (IND/NDA) - candidates can come from a CRO, but some of their experience must be from within a company development their own pharma products.
  08/06/2019 Rho Senior Nonclinical Research Scientist

  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

 06/18/2019 Rho  Director, Regulatory Operations

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.

 

 

 

 

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