[Iur-29] - Regulatory Manager - Cmc Biologics (Various European Locations)

hace 7 días


Alcobendas, España Parexel A tiempo completo

When our values align, there's no limit to what we can achieve.Are you an experienced regulatory professional looking for a new opportunity?We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic teamThis is a client dedicated project, and the role can be office or home based in various European locations.As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.Primary Tasks & Responsibilities:Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.Assess change controls and provide regulatory assessments of quality changes in production and quality control.Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.Identify, escalate, and mitigate risks associated with regulatory procedures and activities.Experience and Knowledge Requirements:University-level education, preferably in Life Sciences, or equivalent by experience.Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.Strong understanding of CMC and post-approval regulatory requirements.Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.Knowledge of biological processes.Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation.Understanding of qualification/validation principles.Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.Team spirit, flexibility, accountability, and organizational skills.Fluent in English (written and spoken).
French, Italian and German would be a strong plus.
#J-18808-Ljbffr



  • Alcobendas, España Discover International A tiempo completo

    Key Responsibilities: Regulatory CMC Strategy & Life Cycle Management: Lead and support the development and execution of global regulatory CMC strategies for large-molecule products, with a focus on analytical life cycle management.Manage post-approval regulatory activities, including CMC variations, supplements, and amendments related to analytical...

  • Regulatory Manager

    hace 5 días


    Alcobendas, Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.Are you an experienced regulatory professional looking for a new opportunity?We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic teamThis is a client dedicated project, and the role can be office or home based in various European...

  • Regulatory Manager

    hace 4 días


    Alcobendas, Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.Are you an experienced regulatory professional looking for a new opportunity?We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic teamThis is a client dedicated project, and the role can be office or home based in various European...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    Parexel is looking for an experienced CMC Regulatory Manager to lead our post-approval regulatory activities for biological products.Main TasksDevelop comprehensive submission plans for post-approval CMC activities.Conduct thorough assessments of quality changes in production and quality control.Evaluate study reports from quality control and production...


  • Alcobendas, Madrid, España Cmc Markets A tiempo completo

    CMC Markets is one of the world's leading online financial trading businesses, listed on the London Stock Exchange. We serve retail and institutional clients through regulated offices and branches in 14 countries. Our award-winning online and mobile trading platform enables clients to trade thousands of financial instruments across shares, indices,...

  • Compliance Risk Manager

    hace 24 horas


    Alcobendas, Madrid, España Cmc Markets A tiempo completo

    **Company Overview**CMC Markets is a leading online financial trading business with a global presence. Since its inception in 1989, the company has grown to become one of the largest players in the industry.The firm is listed on the London Stock Exchange and serves clients across 14 countries through its regulated offices and branches.**Job Description**We...


  • Alcobendas, España Reconocida Empresa A tiempo completo

    ALTEN Spain, a leading force in the IT, Engineering and Life Sciences industries, is currently seeking a dedicated and skilled CMC Specialist.Within 30 years, ALTEN has become a leader in both outsourced Engineering and IT Enterprise Services.ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    Parexel is seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team. As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.Key ResponsibilitiesDevelop...

  • Especialista En Cmc

    hace 2 semanas


    Alcobendas, España Alten A tiempo completo

    ALTEN Spain, a leading force in the IT, Engineering and Life Sciences industries, is currently seeking a dedicated and skilled CMC Specialist.Within 30 years, ALTEN has become a leader in both outsourced Engineering and IT Enterprise Services.ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the...


  • Alcobendas, España Cmc Markets A tiempo completo

    Since launching in 1989, CMC Markets has become one of the world's leading online financial trading businesses.CMC is listed on the London Stock Exchanges and serves retail and institutional clients through regulated offices and branches in 14 countries.CMC offers an award-winning online and mobile trading platform, enabling clients to trade up to 10,000...


  • Alcobendas, Madrid, España Cmc Markets A tiempo completo

    **About Us**At CMC Markets, we value exceptional talent that drives our success. We are committed to recruiting, developing, and retaining skilled professionals who share our passion for excellence.As a Senior Regulatory Affairs Specialist, you will play a crucial role in shaping our compliance strategy and ensuring we remain at the forefront of regulatory...


  • Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    About the Role:We are looking for a highly motivated and experienced Sales Manager for Biologics to join our team in Spain. As a member of our medical sales team, you will play a critical role in promoting our company's products and increasing sales revenue.Key Accountabilities:Developing and implementing sales strategies to increase market share and promote...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    Job DescriptionWe are seeking a talented Regulatory Manager to join our dynamic team. As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities.


  • Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    Biocon Biologics is a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives, and we do this by fostering a culture of affordable innovation, patient centricity, and disruptive thinking.We are a multicultural global company where employees have a purpose and passion to work closely with partners and...


  • Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    Job OverviewWe are seeking a highly skilled and experienced professional to join our team as a Customer Service and Commercial Assistant. As a key member of our sales and marketing operations team, you will play a pivotal role in helping us execute our growth and market penetration strategies for our expanding biologics portfolio in Spain.In this role, you...


  • Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    Company Overview:Biocon Biologics is a leading company in the biosimilars revolution, where patients come first. We are creating a model for the future of healthcare for all by fostering a culture of affordable innovation, patient centricity, and disruptive thinking.We have proven end-to-end expertise in the field of biosimilars, from its development,...


  • Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    Requirements and QualificationsA Bachelor's degree in Pharmacy or a Science stream, with a Master's in Pharmacy or a post-graduation in a Science stream. The ideal candidate should have 5-10 years of pharmaceutical sales experience and at least one year of leadership experience in a sales team. Experience in similar therapy areas is desirable.Biocon...


  • Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    **Company Overview**Biocon Biologics is a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity, and disruptive thinking.We are a multicultural global company with a proven end-to-end expertise in the field of biosimilars, from...


  • Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    Biocon Biologics is a pioneering company in the biosimilars industry, committed to making high-quality affordable healthcare accessible to all.We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients.We have a long-term commitment to bring high-quality affordable biosimilars to patients...

  • Client Support Manager

    hace 24 horas


    Alcobendas, Madrid, España Biocon Biologics A tiempo completo

    Company OverviewBiocon Biologics is a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity, and disruptive thinking.As a key member of our team, you will play a pivotal role in helping us execute sales, marketing, and access...