Regulatory Affairs Consultant
4 tygodni temu
When our values align, there's no limit to what we can achieve.
Parexel Consulting is seeking a talented and experienced CMC Regulatory Affairs Professional to join our team as a Regulatory Affairs Consultant. In this role, you will have the opportunity to utilize your expertise in CMC, exceptional communication skills, and strong writing experience, contributing to our clients' success in the pharmaceutical industry. This position offers exposure to novel technologies and a wide range of responsibilities, from clinical trials to post approval and maintenance.
As the Regulatory Affairs Consultant, you will collaborate closely with a multinational pharmaceutical company, ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports, amendments, supplemental applications, and maintenance of approved marketed products.
This role can be home or office based in various Eruopean locations.
Your key responsibilities will include:
Assisting in the technical review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.
Ensuring that documents meet established regulatory requirements in terms of content and structure.
Serving as a liaison between various functional groups, program teams, international regulatory bodies, and business partners, proposing solutions based on your technical experience and identifying potential project timeline delays.
Maintaining Regulatory CMC documentation.
Managing related databases and submission schedules.
Assisting in the development of submission plans and project timelines.
Preparing for and interacting with regulatory agencies during drug submissions, responding to inquiries, and participating in regulatory agency inspections.
Skills and Experience required for the role:
University degree in a scientific field
At least 5 years of relevant experience in the pharmaceutical industry or a regulatory authority
Successful experience in delivering CMC sections of marketing authorizations, investigational drugs, and life cycle management of commercial products.
Knowledge of EMA guidance, regulations, and ICH/GMP requirements.
Previous regulatory experience with small molecule
Experience with EU submissions via the Centralised Procedure and national procedures.
Experience with extension applications for new strengths and/or pharmaceutical dosage forms.
Experience supporting the preparation of CMC documentation for IMPDs and new product EU MAAs would be advantageous.
Ability to work independently and within project teams or committees, demonstrating accountability in achieving group goals and key project milestones.
Fluent in English written and spoken
-
Regulatory Affairs Expertise Opportunities
4 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatUnlocking 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...
-
Regulatory Affairs Associate
5 dni temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. Are you passionate about regulatory affairs in the life science industry? Do you thrive in a dynamic team environment and enjoy managing complex projects? Parexel is seeking a talented Regulatory Affairs Associate to join our growing team! As a Regulatory Affairs Associate at...
-
CMC Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel 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...
-
Principal Regulatory Affairs Consultant
3 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong...
-
Junior Regulatory Affairs
3 miesięcy temu
Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etatManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...
-
Regulatory Affairs Project Lead
2 tygodni temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are currently looking for a Senior Regulatory Affairs Consultant (Project Lead) ! As a Senior Consultant you will be responsible for leading internal projects on behalf of Parexel Clients. A Senior Consultant provides a broad range of consulting services and works within project...
-
Senior Regulatory Affairs Manager
3 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies...
-
Regulatory Affairs Consultant Expert
4 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel, 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...
-
Regulatory Affairs Expert
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatCompany OverviewWe are seeking a highly skilled Regulatory Affairs Expert to join our international team.Job DescriptionIn this role, you will be responsible for coordinating lifecycle management procedures, ensuring timely submissions of high-quality dossiers, and managing validation issues. You will also work closely with colleagues to complete databases...
-
Principal Regulatory Affairs Consultant
4 tygodni temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. Parexel, a leading Clinical Research Organization (CRO), is 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. The ideal candidate will...
-
International Regulatory Affairs Professional
3 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatAre you looking for a challenging opportunity in the pharmaceutical industry?Randstad Polska is seeking an ERMC Specialist to join our international Regulatory Affairs Team.We offer:A 12-month employment contract with the possibility of extensionHybrid work arrangement (2 days a week remote work)A comprehensive benefits package, including medical care,...
-
Regulatory Affairs Data Management Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our international team at Randstad Polska. This role involves working closely with our clients in the pharmaceutical industry, providing expertise in regulatory affairs data management.Company OverviewOur client is an international company from the pharmaceutical industry,...
-
Regulatory Affairs Professional
3 miesięcy temu
Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etatManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...
-
Regulatory Affairs Associate
6 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. Parexel, a leading Clinical Research Organization, is seeking a Regulatory Affairs Associate (Labelling) to join our team. As a Regulatory Affairs Associate, you will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements...
-
Regulatory Affairs Acceleration Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel: 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...
-
Regulatory Affairs Specialist
1 miesiąc temu
Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etatJob Summary: Manpower (Agencja zatrudnienia nr 412) is a global company with over 70 years of experience, operating in 82 countries. We have been on the Polish market since 2001 and currently have almost 35 branches across the country. Our goal is to open up new opportunities for candidates, help them find a job that matches their qualifications and...
-
Regulatory Affairs Expert
4 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel 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...
-
Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Boston Scientific Pełny etatUnlock Your Potential in Medical ScienceBoston Scientific, a leader in medical science for over 40 years, offers an exciting opportunity for a Regulatory Affairs Specialist to join our team. With a deep commitment to advancing science for life, we're looking for a skilled professional to help us tackle the challenges that matter most.About the Role:This is...
-
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are seeking experienced Regulatory Affairs professionals 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 Global Country...
-
Regulatory Affairs Professional
1 dzień temu
Warszawa, Mazovia, Polska Procter And Gamble Polska Sp. z o.o. Pełny etatJob Title: Regulatory Affairs Associate/ManagerA competitive salary and benefits package is offered to the successful candidate.Company Overview:We are a leading multinational consumer goods company with a presence in Poland. Our team is dedicated to ensuring compliance with regulatory requirements and providing exceptional customer service.Job...
