Aktualne oferty pracy związane z CMC Regulatory Specialist - Warszawa, Mazovia - GlaxoSmithKline

  • Regulatory Affairs Specialist for Global CMC

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    At TN Poland, we are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our CMC team. This role will involve supporting global CMC regulatory strategies and documentation.This is an exciting opportunity for someone who wants to continue their career path in CMC or Regulatory Affairs. If you have experience in the pharmaceutical...

  • Global CMC Regulatory Strategist

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    We are searching for a skilled Global CMC Regulatory Strategist to support our CMC team. As a key member of our team, you will be responsible for developing and implementing global CMC regulatory strategies and documentation.Your first-hand experience in CMC or other regulatory affairs areas and university degree in Life Sciences or a related field will be...

  • CMC Regulatory Compliance Expert

    7 dni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    SalaryPlease note that salary information is not disclosed.Job DescriptionThis is an exciting opportunity to lead selected initiatives within CMC RA/GRA and supervise and provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or more product(s).

  • CMC Regulatory Strategy Expert

    6 dni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    About the RoleThe Regulatory Affairs Director will play a pivotal role in shaping the future of global regulatory strategies for pharmaceutical products.This is an exciting opportunity to lead high-performing teams, drive strategic initiatives, and collaborate with global leaders to ensure compliance, innovation, and excellence throughout the product...

  • CMC Regulatory Expert with Strategic Thinking

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    We are looking for a talented CMC Regulatory Expert with strong strategic thinking and problem-solving skills. As a key member of our CMC team, you will be responsible for supporting global CMC regulatory strategies and documentation.If you have a background in the pharmaceutical industry and are passionate about regulatory affairs, we encourage you to...

  • CMC Regulatory Professional Wanted

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Job ResponsibilitiesDevelop 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...

  • Senior Regulatory Specialist in Pharmaceutical Industry

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    TN Poland is seeking an experienced Senior Regulatory Specialist to join our team. As a key member of our CMC team, you will be responsible for supporting global CMC regulatory strategies and documentation.We are looking for someone with first-hand experience in CMC or other regulatory affairs areas and a university degree in Life Sciences or a related...

  • Senior Regulatory Affairs Expert

    15 godzin temu

    Warszawa, Mazovia, Polska CMC Markets Pełny etat

    Job OverviewCredit and Capital Markets regulation is complex and ever-changing, and as a result, organizations need experienced professionals like yourself to help navigate these challenges. At CMC Markets, we provide our customers with access to thousands of global financial instruments through our award-winning online and mobile trading platform.We're...

  • CMC Consultant

    3 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Are you looking for a challenging role that combines technical expertise with business acumen? TN Poland is seeking a highly qualified Principal Regulatory Affairs Consultant to lead their regulatory affairs efforts in Warsaw.The successful candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of...

  • European Compliance Specialist Role

    15 godzin temu

    Warszawa, Mazovia, Polska CMC Markets Pełny etat

    About the RoleThis mid-senior level position requires a highly skilled professional with expertise in regulatory affairs, particularly in the financial services sector. As a Senior Compliance Manager at CMC Markets, you will oversee the development of comprehensive compliance programs, collaborate with cross-functional teams, and provide expert guidance on...

  • Regulatory Affairs Specialist

    2 dni temu

    Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

    Job Description:GSK is a global biopharma company that unites science, technology, and talent to get ahead of disease together. Our ambition is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.We are looking for a skilled Regulatory Affairs Specialist to join our team in Poland. As a key member...

  • Regulatory Affairs Expert

    3 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Parexel, a leading Clinical Research Organization (CRO), is seeking an experienced Principal Regulatory Affairs Consultant to join their team in Warsaw. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This is a...

  • Senior Regulatory Professional

    3 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    TN Poland is seeking a highly qualified Principal Regulatory Affairs Consultant to join their team in Warsaw. The successful candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This is a unique opportunity for a highly qualified...

  • Biologics Regulatory Specialist Needed

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    About the RoleThis is a unique opportunity to leverage your expertise in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry. As a CMC Regulatory Manager, you will be responsible for developing and implementing submission strategies and plans.You will work closely with various departments to ensure compliance...

  • Global Regulatory Expert

    2 dni temu

    Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

    About the Role:GSK's Global Regulatory Centres are responsible for regulatory affairs functions, bringing together operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance, and lifecycle management dossiers.We are seeking a highly skilled Regulatory...

  • Regulatory Affairs Manager

    4 tygodni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Regulatory CMC ManagerWe are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products.About the RoleIn this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and...

  • Regulatory Affairs Manager

    7 dni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This...

  • senior manager regulatory affairs

    4 tygodni temu

    Warszawa, Mazovia, Polska Randstad Pełny etat

    **Job Title:** Manager, Regulatory AffairsContribute to Global Development and Lifecycle ManagementYou will lead the development and execution of global CMC regulatory strategies, ensuring compliance with regulatory requirements and representing Global CMC Regulatory Affairs in cross-functional and external collaborations.About This Opportunity:This is an...

  • Post-Approval Regulatory Expert

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    RequirementsUniversity-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...

  • Regulatory Affairs Manager Role

    4 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    About the JobWe are seeking an experienced regulatory professional to join our dynamic team as a CMC Regulatory Manager. This client-dedicated project offers flexibility, with the option to work from home or office in various European locations.As the CMC Regulatory Manager, you will play a key role in our company's worldwide post-approval regulatory...

CMC Regulatory Specialist

1 tydzień temu

Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

GRC Regulatory Affairs Professional

The Renewals CMC Team within the Global Regulatory Centres (GRC) is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. We are seeking a highly skilled Regulatory Specialist with expertise in Chemistry, Manufacturing, and Controls (CMC).

Key Responsibilities:

  • Evaluate and implement innovative solutions for CMC regulatory processes, policies, and systems.
  • Manage multiple CMC renewals assignments for pharmaceutical and vaccines products, including response to questions from regulatory agencies.
  • Collaborate with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies worldwide to deliver high-quality dossiers on time.
  • Act as subject matter expert in regulatory processes and monitor regulatory intelligence.

Job Requirements

  • Relevant degree or equivalent experience in regulatory affairs, chemistry, or a related field.
  • Proven track record in managing CMC regulatory submissions and responding to agency queries.
  • Excellent communication and collaboration skills.

Benefits

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.