Jobbörse
Finde Jobs in deiner Nähe – ob vor Ort, hybrid oder remote.- Ähnliche Jobs zu: Regulatory Affairs Manager CMC
Manager, Regulatory Affairs
Monte Rosa TherapeuticsBoston
Regulatory Affairs CoordinatorResponsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and inter
Manager, Quality Assurance & Regulatory Affairs
PerkinElmerUnited StatesManager, Quality Assurance & Regulatory AffairsWhen joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribu
Vice President, Regulatory Affairs
Rhythm Pharmaceuticals Inc.BostonCompany Overview Rhythm is a global, commercial‑stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop
Vice President, Regulatory and Head of Regulatory Affairs
Sagimet BiosciencesCaliforniaThe VP of Regulatory and Head of Regulatory Affairs will shape and execute regulatory strategies and lead and manage submissions to support clinical development and regulatory compliance for Sagimet.
Global Regulatory Affairs VP
Sight SciencesMenlo ParkSight Sciences in Menlo Park is seeking a Vice President of Regulatory Affairs to oversee all regulatory matters for both U.S. and international spheres. You will manage regulatory strategy for vital
Strategisch adviseur Pricing & Regulatory Affairs
SchipholSchiphol
Nice to know (you) Wij zoeken een strategisch adviseur Pricing & Regulatory Affairs. Onze afdeling is verantwoordelijk om invulling te geven aan de economische regulering van Schiphol en daarmee de
Associate Director, Regulatory Affairs Operations
Third Rock VenturesCambridgeManager, Regulatory OperationsAt Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources wi
Water Quality/Regulatory Affairs Supervisor
Palmdale Water DistrictPalmdaleFLSA Status: Exempt1st Review of application: Week of July 8, 2026JOB SUMMARY To plan, organize, direct, and supervise water quality laboratory operations and related regulatory compliance activities
Strategisch adviseur Pricing & Regulatory Affairs
SchipholAmsterdamNice to know (you) Wij zoeken een strategisch adviseur Pricing & Regulatory Affairs. Onze afdeling is verantwoordelijk om invulling te geven aan de economische regulering van Schiphol en daarmee de
Vice President of Regulatory Affairs
Boulevard BioBostonBoulevard Bio is a private, clinical‑stage biotechnology company dedicated to developing best‑in‑class medicines to address B cell driven autoimmune diseases of significant clinical and commercial unm
Regulatory Affairs Associate (entry level)
GrifolsUnited Statestable.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifo
Remote Regulatory Affairs & Quality Data Analyst
Maker’s Pride, LLCDowners GroveMaker’s Pride, LLC is seeking a Regulatory Affairs Analyst to support compliance and quality in Downers Grove, IL. The role involves managing documentation, product specifications, and collaborating a
VP, Regulatory, Clinical Ops & Medical Affairs
DendreonSeal BeachDendreon is seeking a Vice President of Regulatory Affairs, Clinical Operations & Medical Affairs in Seal Beach, CA. This role requires strategic leadership to align regulatory strategies with clinica
Compliance Manager - Regulatory Affairs (m/w/d)
ssw | groupOststeinbek
Job Description SSW ist das perfekte Zusammenspiel von innovativen Handelsstrategien, modernster Technik und einem einzigartigen, interdisziplinär arbeitenden Team. So haben wir uns den Platz an der S
Head of Global Regulatory Affairs and Strategy
Isomorphic LabsCambridgeHead Of Global Regulatory Affairs And StrategyIsomorphic Labs is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to s
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemHephzibahHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemGrovetownHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
Associé(e) aux affaires réglementaires / Regulatory Affairs Associate
Knight Therapeutics CanadaLaval
Ce poste offre une formule de travail hybride, permettant d’effectuer 50 % de ses tâches en télétravail. Cette approche favorise un équilibre entre performance et flexibilité, tout en maintenant une c
Executive VP, Regulatory, Clinical Ops & Medical Affairs
SitcancerSeal BeachSitcancer is seeking a Vice President of Regulatory Affairs, Clinical Operations, and Medical Affairs to provide strategic leadership for compliance and product development. This role is pivotal, requ
TEAM LEAD REGULATORY AFFAIRS (M/W/D)
STRATEC SEBirkenfeldSTRATEC entwickelt und produziert vollautomatische Analysesysteme für führende Partner in der In-vitro-Diagnostik und im Bereich Life Science. Vom Konzept bis zum fertigen Produkt - wir machen alles i
Regulatory Affairs Coordinator (RN) WMCG Augusta Georgia
Wellstar Health SystemClearwaterHow would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is s
TEAM LEAD REGULATORY AFFAIRS (M/W/D)
STRATEC SEBirkenfeldJob Description STRATEC entwickelt und produziert vollautomatische Analysesysteme für führende Partner in der In-vitro-Diagnostik und im Bereich Life Science. Vom Konzept bis zum fertigen Produkt - wi
Remote Vice-président chargé des Affaires Réglementaires / VP, Regulatory Affairs
AllucentBrossardChez Allucent™ , nous nous engageons à aider les petites et moyennes entreprises biopharmaceutiques à naviguer efficacement dans le monde complexe des essais cliniques afin d'apporter des traitements
Remote Vice-président chargé des Affaires Réglementaires / VP, Regulatory Affairs
AllucentChamblyChez Allucent™ , nous nous engageons à aider les petites et moyennes entreprises biopharmaceutiques à naviguer efficacement dans le monde complexe des essais cliniques afin d'apporter des traitements
Remote Vice-président chargé des Affaires Réglementaires / VP, Regulatory Affairs
AllucentSt. ThomasChez Allucent™ , nous nous engageons à aider les petites et moyennes entreprises biopharmaceutiques à naviguer efficacement dans le monde complexe des essais cliniques afin d'apporter des traitements
Manager, Regulatory Affairs
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
Über
Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/interpretations. May determine methods and procedures on some assignments and may provide guidance to other lower-level personnel.
ResponsibilitiesCoordinates regulatory workflow, provides regulatory support to the team, and tracks project timelines and budget.
Provides ongoing regulatory support to the project team members.
Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.
Reviews and formats technical documents (pertaining to clinical, chemistry, manufacturing and controls, and non-clinical information). This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.
Participates in assigned Regulatory Affairs initiatives aimed at improving internal Idenix standards and tracking/control systems.
Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes.
Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.
Direct interaction with regulatory agencies on routine matters.
QualificationsBachelors/Masters Degree in a scientific discipline or equivalent with a minimum 8 years of Regulatory Affairs experience.
Must have extensive experience and understanding of CMC requirements for Small Molecule drugs.
Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines.
A working knowledge of electronic publishing and file management systems, preferred.
Excellent understanding of Microsoft Windows, Office, Excel, Project, Outlook, and other common PC applications.
Excellent organizational, presentation, and decision-making skills, and analytical thinking/problem-solving/investigative skills are required.
Certified regulatory affairs professional would be desirable
Sprachkenntnisse
- English
Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klick auf „Jetzt Bewerben”, um deine Bewerbung direkt auf deren Website einzureichen.