Regulatory Affairs Specialist for CMC Submissions

Parexel Consulting is a leading pharmaceutical industry expert seeking a highly skilled and experienced CMC Regulatory Affairs Professional to join our team as a Regulatory Affairs Consultant.Job OverviewThe ideal candidate will possess exceptional communication skills, strong writing experience, and in-depth knowledge of CMC regulations, including EMA...

Parexel is seeking a highly qualified Regulatory Affairs Expert to lead post-approval Chemistry, Manufacturing, and Controls (CMC) activities for small molecule projects.The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of CMC regulations. As a recognized professional in your field of...

Parexel is seeking a talented Regulatory Manager to join our dynamic team.This client-dedicated project can be office or home based in various European locations.As the 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...

Job OverviewParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Senior Regulatory Affairs Specialist to join our team. This role offers a unique opportunity to utilize your technical skills and specialist knowledge to deliver exceptional consulting services to our clients.About the RoleWe are looking for an experienced...

Unlocking the Potential of Regulatory Affairs ExpertsParexel, a leading Clinical Research Organization (CRO), is seeking an experienced Principal Regulatory Affairs Consultant (Associate Director level) to join our team. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval...

Parexel's MissionWe are a leading global biopharmaceutical solutions organization committed to supporting our clients in bringing innovative treatments to market. Our expertise spans the entire product development cycle, from clinical trials to commercialization.Job SummaryWe are seeking an experienced Regulatory Affairs professional to join our dynamic team...

Parexel: A Global Leader in Clinical ResearchWe are seeking an experienced Regulatory Affairs professional to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in emerging markets and non-EU markets.Our...

About the RoleAs a Regulatory Affairs Expert - CMC Product Registration, you will be responsible for managing multiple CMC new files and CTA assignments for Pharma, Biopharm, and Vaccines products. Your primary focus will be on ensuring compliance with Company regulatory processes and external requirements.Key ResponsibilitiesDefine and agree regulatory...

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. As a recognized professional in your field of expertise, you will utilize your skills to deliver exceptional consulting services to our...

Parexel's VisionAt Parexel, we are seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. This role is an excellent opportunity to utilize your regulatory affairs experience and project management skills to deliver...

About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Professional, New Registration CMC to join our Global Regulatory Centres team.The successful candidate will be responsible for managing multiple CMC new files and CTA assignments for Pharma, Biopharm and Vaccines products, including responses to questions from regulatory agencies.Your...

About the RoleParexel Consulting is seeking a skilled Regulatory Affairs Consultant to join our team. As a key member of our multinational pharmaceutical company, you will play a crucial role in ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports,...

About the RoleParexel, a leading Clinical Research Organization (CRO), seeks a highly qualified Regulatory Affairs Expert Lead with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines.The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of...

Regulatory Affairs Specialist RoleWe are seeking a highly motivated individual with a background in Polish and European regulatory law to support our team in delivering high-quality pharmaceutical products.Key Responsibilities:Ensure compliance with Polish and European regulations for pharmaceutical products.Liaise with internal departments and external...

Parexel is a leading Clinical Research Organization (CRO) that seeks a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule.The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC...

About the Role:We are seeking a highly skilled Senior Regulatory Affairs Specialist, Chemistry Manufacturing and Controls to join our team at GSK. The successful candidate will be responsible for ensuring that our pharmaceutical and vaccine products are safe, effective, and of high quality for patient use.Key Responsibilities:Manage multiple CMC new files...

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team. As a key member of the team, you will be responsible for coordinating lifecycle management procedures, ensuring timely submission of high-quality dossiers, and managing validation issues.Key Responsibilities:Coordinate...

About the RoleWe are seeking a skilled Regulatory Affairs Specialist to join our team at 9605 GSK Services Sp z o.o. in Poland.Job DescriptionThis is a dynamic and challenging role that requires strong communication skills, attention to detail, and the ability to work effectively in a matrix environment.The successful candidate will be responsible for...

Job Description:Novo Nordisk is seeking a highly skilled Regulatory Affairs Specialist to join our team in Poland. As a key member of our Regulatory and Pharmacovigilance Team, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). Your main responsibilities...

Job SummaryAs a Regulatory Affairs Specialist at Novo Nordisk, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA).Key Responsibilities:Preparing and submitting Regulatory documentation for New Drug Applications, post-marketing variations and renewal...