Regulatory Affairs Specialist

6 days ago


York, Pennsylvania, United States PSC Biotech Full time
Job Overview

PSC Biotech is a leading provider of life sciences services, ensuring the highest standards for healthcare products. We are seeking an experienced Regulatory Project Manager to join our team.

">Responsibilities
  • Lead and manage regulatory projects from initiation to completion, ensuring timely deliverables and milestones.
  • Develop and implement regulatory strategies for drug products, including sterile injectable products.
  • Provide guidance and expertise to cross-functional teams during product development and regulatory requirements.
  • Proactively coordinate resource allocation, tracking progress and evaluating timelines, schedules, risks, and objectives.
  • Assess and communicate regulatory risks and opportunities, identifying potential risks and implementing corrective actions.
Requirements

We are looking for a highly motivated and experienced professional with a strong background in sterile injectables. The ideal candidate will have a Bachelor's or advanced degree in a related science discipline and a minimum of 7+ years of experience in regulatory affairs within the pharmaceutical industry.

Benefits

PSC Biotech offers a competitive salary range of $120,000 - $160,000 per year, depending on experience. In addition to a comprehensive benefits package, we offer opportunities for growth and development in a dynamic and global environment.



  • York, Pennsylvania, United States PSC Biotech Full time

    PSC Biotech is a leading provider of essential services to the life sciences industry. We are seeking a highly motivated and experienced Regulatory Affairs Associate to join our team in York, PA. In this role, you will support regulatory requirements for a wide range of drug product types, ensuring compliance with global regulatory standards.About the...


  • York, Pennsylvania, United States Larson Maddox Full time

    A dynamic position has become available at Larson Maddox as a PBM Counsel. In this role, you will provide expert guidance on complex 340B Contract Pharmacy matters, pharmaceutical product procurement work, medical reimbursement issues, and Antikickback regulations. You will also be responsible for specialty pharmacy regulations and PBM matters.Key...


  • York, Pennsylvania, United States PSC Biotech Full time

    We are seeking a highly motivated and experienced Regulatory Project Manager with a strong background in sterile injectables to join our team at PSC Biotech.About the RoleThe successful candidate will provide strategic guidance and facilitate seamless collaboration, serving as the central point of contact. Key responsibilities include coordinating resources,...


  • York, Pennsylvania, United States PSC Biotech Full time

    PSC Biotech is passionate about bringing the best and brightest together to form something truly special. We are seeking a talented Regulatory Affairs Associate to join our team in York, PA. In this role, you will play a key part in ensuring compliance with global regulatory standards for a wide range of drug product types.About the CompanyPSC Biotech...


  • York, Pennsylvania, United States Anonymous Full time

    At Anonymous, we are seeking a highly skilled Strategic Compliance Expert to join our team in New York City.This key hire will play a pivotal role in leading our day-to-day compliance program as we continue to build an industry-leading team.The ideal candidate will have:Strong knowledge of the Investment Advisers Act of 1940 and Investment Company Act of...


  • York, Pennsylvania, United States PSC Biotech Full time

    Company OverviewPSC Biotech, a leading provider of innovative quality management and regulatory compliance solutions, is seeking a highly skilled Content and Design Specialist. Our cloud-based software empowers organizations to streamline processes, ensure compliance, and improve efficiency. With expertise in pharmaceutical, medical device, and regulated...


  • York, Pennsylvania, United States MSCCN Full time

    Job Title: International Trade Document SpecialistAs an International Trade Document Specialist at MSCCN, you will play a critical role in supporting the import/export process by preparing and reviewing shipping documents. You will work closely with our logistics team to ensure all documents meet regulatory requirements.Responsibilities:Prepare and review...


  • York, Pennsylvania, United States Traditions Bank Full time

    Job SummaryWe are seeking a skilled and experienced Financial Services Specialist to join our team at Traditions Bank.The ideal candidate will have strong analytical and problem-solving skills, with the ability to work accurately and efficiently in a fast-paced environment.About the RoleThis part-time (24 hours/week) position earns an estimated $16-$18.50...


  • York, Pennsylvania, United States RHI Magnesita Full time

    Elevate Your Career with RHI MagnesitaAbout the RoleWe are seeking an experienced EHS Services Specialist to join our team at RHI Magnesita. As a key member of our organization, you will play a critical role in ensuring the health and safety of our employees, contractors, and customers.With a strong focus on risk management and compliance, this position will...


  • York, Pennsylvania, United States Rise Baking Company Full time

    Join the Rise Baking Company team as a Quality Assurance Specialist and play a crucial role in ensuring the highest standards of product quality and food safety.About the RoleThis is an exciting opportunity for a detail-oriented and organized individual to join our manufacturing team. As a Quality Assurance Specialist, you will be responsible for conducting...


  • York, Pennsylvania, United States SpiriTrust Lutheran Full time

    About the RoleSpiriTrust Lutheran is seeking a dedicated Sustainability and Operations Specialist to oversee maintenance and repair operations at The Village at Kelly Drive in York, PA.Key ResponsibilitiesSustainable Practices: Implement energy-efficient practices and maintain a safe working environment.Maintenance Coordination: Coordinate with team members...


  • York, Pennsylvania, United States Jackson HealthPros Full time

    Unlock Career Advancement OpportunitiesJackson HealthPros, a leading provider of healthcare staffing solutions, is seeking an experienced Travel Radiologic Imaging Specialist to join their team. This 13-week assignment in York, Pennsylvania, offers a unique chance to expand your professional horizons and contribute to the delivery of high-quality patient...


  • York, Pennsylvania, United States Rise Baking Company Full time

    Rise Baking Company is seeking a Product Quality Assurance Specialist to join our team on the first shift.**Job Overview**The Product Quality Assurance Specialist is responsible for ensuring product quality and food safety by following customer, regulatory, company, and SQF requirements. This involves conducting line audits, verifying raw and finished...


  • York, Pennsylvania, United States UPMC Full time

    We are seeking a licensed Psychologist or LCSW to join our team of interdisciplinary members at UPMC PinnacleHealth Psychological Associates (PHPA). The successful candidate will provide outpatient psychological services, including individual therapy, family therapy, group therapy, and psychological testing. Our full-time position offers a flexible schedule...


  • York, Pennsylvania, United States Aerotek Full time

    Job OverviewAerotek is seeking a skilled Quality Control Tech 1 for the 2nd Shift in York, Pennsylvania. This hands-on role involves ensuring adherence to GMP regulations and quality management systems.About the RoleWe are looking for an experienced individual to join our team as a Contract-to-Hire Quality Control Tech 1. The successful candidate will work...

  • Delivery Driver

    4 days ago


    York, Pennsylvania, United States Airgas Full time

    Delivering ExcellenceWe are seeking a motivated and detail-oriented Logistics Delivery Specialist to join our team in York, PA. As a key member of our logistics team, you will be responsible for delivering compressed gas cylinders to local and regional business customers while ensuring the highest level of safety and compliance with regulatory guidelines.Key...


  • York, Pennsylvania, United States PSC Biotech Full time

    Job OverviewPSC Biotech, a leading provider of cloud-based quality management and regulatory compliance solutions, seeks an experienced Digital Marketing Specialist. The successful candidate will be responsible for enhancing the company's online presence through effective website management, SEO strategies, paid campaign execution, and competitive...


  • York, Pennsylvania, United States YWCA York Full time

    Staff Accountant RoleWe are seeking a highly skilled and motivated Staff Accountant to join our Finance Team at YWCA York. As a key member of the team, you will be responsible for maintaining the financial records, preparing financial statements, and ensuring compliance with regulatory requirements.Main Duties:Manage the general ledger, ensuring accurate and...


  • York, Pennsylvania, United States Magnet Medical Full time

    Job SummaryMagnet Medical seeks an Electrophysiology Lab RN Specialist to work in York, Pennsylvania.Key Responsibilities:Pre-Procedure Assessment and Preparation:Conduct thorough pre-procedure assessments of patients, including reviewing medical history, current medications, allergies, and previous cardiac conditions.Educate patients and their families...


  • York, Pennsylvania, United States Magnet Medical Full time

    Job OverviewMagnet Medical, a leading healthcare provider, is seeking a skilled Diagnostic Imaging Specialist to join our team in York, Pennsylvania.Job SummaryWe are looking for an experienced CT Technologist to operate computed tomography scanners and perform diagnostic imaging procedures for patients. The successful candidate will be responsible for...