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Volunteer Spotlight

Volunteer Spotlight
Each month, RAPS turns the spotlight on a member making an impact in RAPS and on the regulatory community. These members are the backbone of the Regulatory Affairs Professionals Society and an inspiration for others. If you are interested in being highlighted or nominating another member for the spotlight, please contact Austen Gage at agage@raps.org.

Regulatory Job Openings

  • KINDRED REHAB HOSP EAST VALLEY LLC, Arizona, Director of Quality Opportunity Dignity East Valley Rehabilitation Hospital - Chandler, AZ Dignity Health East Valley Rehabilitation Hospital is a joint venture operation and free-standing Post-Acute Inpatient Rehabilitation Hospital between Dignity Health and Kindred Healthcare. Our two-story, 58,000-square-foot facility includes a stroke unit, physical therapy gym and 50 beds to serve patients recovering from significant neurological injury, illness and trauma and similar medical conditions. Located at 1515 W. Chandler Blvd., and employs approximately 190 staff members. The DCQPI assumes responsibility and accountability for the hospital-wide Continuous Quality and Performance Improvement program. The DCQPI will assist the CEO/leadership and Medical Staff to establish priorities for Performance Improvement. He/she ensures that disciplines in the hospital work collaboratively to plan and implement Performance Improvement activities. The DCQPI will focus on measuring, analyzing and trending information in order to improve outcomes. He/she will assure ongoing monitoring of performance to ensure that improvements are sustained. The DCQPI will direct and assist in compliance with federal and state regulations and accreditation standards . High School diploma or GED equivalent required; or degree of higher education preferred. Registered Nurse with current licensure in the State of Arizona, preferred. Certification by APIC (American Practitioners of Infection Control), and NAHCQ (National Association of Health Care Quality) preferred BSN or BS/BA preferred. Two years of experience in an acute hospital or rehabilitation setting preferred. Previous supervisory experience required. Current Basic Life Support/CPR Card preferred Demonstrated ability to plan, coordinate, and evaluate PI activities; effective oral and written communication skills and proficiency in basic computer skills required. Working knowledge of staff development and the educational process, quality improvement, infection control/employee health, and safety/risk management standards. Effective oral and written communication skills, in English with additional languages preferred; proficiency in basic computer skills required. Job : Compliance/Quality/Risk Primary Location : AZ-Chandler-CHC PR & MSA-DIGNITY-KINDRED REHAB HOSP EAST VALLEY LLC Organization : 3199 - CHC PR & MSA-DIGNITY-KINDRED REHAB HOSP EAST VALLEY LLC Shift : Day
  • Kindred Hospital Paramount, California, What makes Kindred Healthcare a great place to work? Our people, of course! Our Quality Coordinator answers this special calling because they have a fundamental, internal drive to directly help people. In return, we serve, develop and respect our employees in environments created to optimize their job effectiveness, experience, and satisfaction. This is who we are. Who are you? To succeed in our high-energy, high reward environment, our clinicians provide compassionate critical care and deliver exceptional patient experiences, meaningful outcomes, and bonds for life. As the most acute level of care in Kindred's continuum, our transitional care hospitals offer the same critical care patients receive in a traditional hospital or intensive care unit , but for an extended recovery period. Our leadership play a vital role in the recovery process for chronic, critically ill and medically complex patients. As a Quality Coordinator you will: Summary: The Quality Coordinator reports to the Director of Quality Management and will assist with data collection and analysis, creating aggregate data reports, open record review, survey preparation and on-going survey compliance, event investigation and management, and other activities related to hospital performance improvement. Work is divided between reviewing open electronic and paper record, on and off the patient unit. Computer data entry and report writing, attendance at meetings and data analysis. Quality Coordinator, Quality Management, Risk Management, CPHQ, Hospital Risk Management, Hospital Quality Management, Hospital Quality, Hospital Risk, Risk Mgr, Quality Mgr, Quality Analysis, Quality Analyst, Quality Clinician, Acute Quality, LVN, LPN, RN, Nurse, Healthcare Quality, Performance Improvement, 90723 Education: From an accredited program leading to licensure as an LPN/LVN or RN Licenses/Certification: Current RN licensure or LPN/LVN licensure Experience: 3 years clinical experience and health care and performance measurement or improvement experience Job : Compliance/Quality/Risk Primary Location : CA-Paramount-Kindred Hospital Paramount Organization : 4003 - Kindred Hospital Paramount Shift : Day
  • Nationwide, Senior Regulatory CMC Strategist – Complex Biologics/Combined Products ; Full-time and part-time permanent roles are available Location: Remote: 100% home-based with ~25% travel Are you a senior-level Regulatory CMC Strategist and Writer with 6 to 10+ years of experience guiding biotechnology products through the full development lifecycle? We are looking for amazing candidates with the end-to-end knowledge and line-of-sight needed to ensure successful outcomes with regulators and facilitate a smooth path to licensure. We want someone who can lead or support, as needed, Regulatory CMC interactions with global health agencies, whether through submission packages, virtual or face-to-face meetings, responses to questions, or pre-approval inspections. We believe success is based on building a foundation of trust with both clients and regulators, which is achieved through: thoughtful assessments and communication of risks; formulating risk mitigation strategies; collaborating effectively and influencing decision-makers for the best technical packages, positioning, and messaging; and honoring commitments to ensure high-quality, on-time deliverables. The candidate will regularly develop and review key technical documentation such as marketing applications, protocols, reports, development plans, investigations, change controls, post-approval supporting documentation, SOPs, and policies. Candidates with expertise in process validation is a plus. We are specifically looking for professionals with the following product experience: Complex biologics Cell and gene therapies Live and attenuated virus vaccines Therapeutic proteins, fusion proteins, recombinant proteins, immunoglobulins, antibody-drug conjugates Microbiome therapie Small molecules Novel excipients and adjuvants Mammalian, bacterial, yeast, and insect host cell lines Virus seed banks Solutions for injection and IV administration Biologic/device combination products (Autoinjectors, prefilled syringes, dual-chamber cartridges; Electroporation) Lyophilized products for reconstitution     What We’re Looking For: The Senior-level Regulatory CMC Strategist will help us provide regulatory strategy and technical writing services to biotech, biosimilar, and combination therapy companies engaged in research, development, manufacturing, and clinical trials. Projects span a full range of product types, including biologics, vaccines, gene therapies, tissue and cell therapies, biosimilars, and combination drug-device products. As a senior member of this team you will work collaboratively with other GLOBAL team members and with client companies to support the development of international CMC regulatory strategies and content plans for the lifecycle of products. Successful candidates must have extensive experience in the Regulatory CMC space and possess working knowledge of industry-standard biologics manufacturing and/or analytical techniques. The candidate must be comfortable distilling technical information from multiple sources into concise and well-crafted written deliverables that are aligned with GLOBAL’s highest standards of quality and meet both client and health authority expectations. Crazy-good ninja-like attention to detail and communication skills are absolute musts. As a virtual company, GLOBAL employees work remotely out of their own home offices and must have stable and reliable internet and phone service, and an environment conducive to the type of work and to having professional interactions with team members and clients. Critical to success is being self-motivated and responsible to manage your workload and deliver projects on time without direct supervision. You also need to be friendly, client-focused, and outgoing in asking questions to educate yourself on the technical elements of the project.   What You Will Be Doing: Play a key role in supporting the development of global CMC regulatory strategies and content plans for combination products throughout the lifecycle of the product Implement regulatory strategies and prepare the submission of CMC sections, marketing applications, supplements, and variations Understand the client well enough to ensure the CMC regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP) Interface with Manufacturing, Supply Chain, Quality, CMOs, and other strategic partners Identify risks and diplomatically propose plans to mitigate risks Oversee global and US CMC regulatory support and submissions for various stages of development and commercial products Plan, author, and review CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings Provide technical review and approval of test protocols, reports, and other source documents Assist in negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators Support client teams wherever needed and provide direction on the interpretation and application of global CMC regulations and guidance related to biologics and/or combination products Ensure communication and alignment of the CMC regulatory strategy through partnership and communication with therapeutic area regulatory affairs leaders, project development teams, and all other internal and external stakeholders Maintain a high-level understanding of US and global (ICH, FDA, EMA) regulatory requirements Build positive relationships with clients and co-workers Participate in GLOBAL business development opportunities; attend, represent GLOBAL and occasionally speak at industry conferences Mentor junior GLOBAL CMC team members and participate in developing internal training programs What Qualifications and Skills are Required or Preferred: The ideal candidate will have the following qualifications and experience: REQUIRED: A Bachelor’s degree with 10+ years of regulatory CMC-specific complex biologics, biosimilar, or combination product industry experience OR a Master’s degree with 8+ years of industry experience OR a PhD with 6+ years of industry experience is required (a degree in pharmacy, chemistry, biology, or a related science/technical field is preferred) REQUIRED: At least 6+ years of experience in CMC-specific regulatory strategy role, including planning and ownership of submissions such as marketing applications and briefing documents AND developing CMC regulatory strategy for pre- and post-approval of complex biologics or combination products REQUIRED: Direct experience in the preparation (authoring, editing and review) of regulatory submissions (Module 3) in most of the following submissions IND/IDE/CTA/NDA/BLA/MAA REQUIRED: Significant knowledge of biologics, biosimilars, and/or combination therapy and device regulations Previous experience with medical device submissions PMAs, 510(k)s, IDEs, MAFs, CE Mark Technical Files for those with combination therapy experience is preferred Experience in leading Health Authority meetings (FDA, EMA and national agencies) is preferred Previous experience managing directly/indirectly other people in a matrix team environment is required, with remote experience preferred Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving GLOBAL is an EEO/AA employer committed to providing opportunities to minorities, women, veterans, and individuals with disabilities. The position is home-based in the U.S., but it requires up to 25% travel as needed. We are offering a competitive base salary plus generous benefits, as well as significant bonuses and long-term profit-sharing opportunities (aka, “skin in the game”) upon successful realization of new growth.

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