Regulatory Writing Stellenangebote


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Technik & Ingenieurwesen Technische Dokumentation / Redaktion


1.225 Stellenangebote


Stellenangebote Regulatory Writing Jobs


Job vor 10 Tagen bei Mindmatch.ai gefunden TN Austria

Expert Regulatory Writing (m/w/d)

 • KI Social network you want to login/ join with: Client: Location: Job Category: Other EU work permit required: Yes Job Reference: 46dce25c322e Job Views: 5 Posted:[...]
MEHR INFOS ZUM STELLENANGEBOTSocial network you want to login/ join with: Client: Location: Job Category: Other EU work permit required: Yes Job Reference: 46dce25c322e Job Views: 5 Posted: 14.03.2025 Expiry Date: 28.04.2025 Job Description: Creation and/or update as well as review of regulatory documentation in English according to IVDR incl. PEP, PER, APR, CPR and SVR for existing and new products. Perform Gap-analysis [...]
Job vor 10 Tagen bei Mindmatch.ai gefunden NEVEON Executive Committee Expert Regulatory Writing (m/w/d) • KI Responsibilities Creation and/or update as well as review of regulatory documentation in English according to IVDR incl. PEP, PER, APR, CPR and SVR for existing[...]
MEHR INFOS ZUM STELLENANGEBOTResponsibilities Creation and/or update as well as review of regulatory documentation in English according to IVDR incl. PEP, PER, APR, CPR and SVR for existing and new products Perform Gap-analysis [...]
Job am 02.03.2025 bei Jobleads gefunden

Head of Medical Writing (m/f/d)

 • Hechingen, Baden- Württemberg Führungs-/ Leitungspositionen Its a good feeling to know youre doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment[...]
MEHR INFOS ZUM STELLENANGEBOT[...] maximize writers contributions and career development Familiarity with medical devices, MDD and MDR Accomplished use of MS Word, Power Point and Adobe Acrobat Proficiency in written and spoken English Practice in managing medical writers preferred. Your Contribution Establish medical and regulatory writing best practices (templates, SOPs, work instructions, document review, document timelines) to ensure consistency and quality of documents Lead writing team [...]
Alle Medical Writing Stellenangebote anzeigen
Job am 20.02.2025 bei Jobleads gefunden Clinical Dossier Lead Consultant • Basel- Landschaft Führungs-/ Leitungspositionen Beratungs-/ Consultingtätigkeiten Clinical Dossier Lead Consultant Location: Basel Contract: 6-month, with potential for extension Start Date: ASAP Workload: Full-time Overview: Our client, a Swiss pharmaceutical company specializing[...]
MEHR INFOS ZUM STELLENANGEBOT[...] with a focus on dossier preparation and submissions. Proven track record of leading NDA and MAA submissions in the pharmaceutical/ biotech industry. Ability to navigate and improve poorly structured dossiers with a critical, problem-solving mindset. Strong analytical, data interpretation, and regulatory writing skills. Excellent communication and leadership skills, with experience guiding cross-functional teams. Please apply directly online with your CV and only [...]
Job vor 11 Tagen bei Neuvoo gefunden Pro Pharma Group

Senior Manager, Regulatory Sciences-Development

 • germany, Scientific. For the past 20 years, Pro Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med[...]
MEHR INFOS ZUM STELLENANGEBOT[...] (MSc/ PhD) in a relevant field preferred. Bachelors degree in a life science field (e. g. , biology, pharmacy, pharmacology, toxicology) or a related discipline necessary. 8-10+ years experience within regulatory sciences for development products preferred Expertise with nonclinical/ clinical regulatory writing and advanced knowledge of nonclinical/ clinical strategies for development products. Experience of leading and delivering successful projects within budget and [...]
Alle Senior Manager Stellenangebote anzeigen
Job am 13.03.2025 bei Neuvoo gefunden Greiner AG Expert Regulatory Writing (all genders) (m/w/d) • Kremsmünster, AT
Vergütung / Gehalt: EUR 4850,- Homeoffice möglich Flexible Arbeitszeiten Expert Regulatory Writing (all genders) Dienstgeber: Greiner Bio-One GmbH Arbeitsort: Kremsmünster Vertragsart: Unbefristet Your challenge Creation and/or update as well as review of regulatory documentation[...]
MEHR INFOS ZUM STELLENANGEBOTExpert Regulatory Writing (all genders) Dienstgeber: Greiner Bio-One GmbH Arbeitsort: Kremsmünster Vertragsart: Unbefristet Your challenge Creation and/or update as well as review of [...]
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Neu Job vor 6 Std. bei NewScientist Jobs gefunden Tango Therapeutics

Vice President, Regulatory Affairs

 • Boston, Massachusetts, United States, Boston Führungs-/ Leitungspositionen Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment[...]
MEHR INFOS ZUM STELLENANGEBOT[...] Control (CMC) , Pharmacovigilance and Quality, related matters, and their intersection with Regulatory Affairs Strong knowledge of drug and small molecule development regulations and guidelines including ICH, FDA, and EMA Excellent written and verbal communication skills, strong technical knowledge, including regulatory writing Strong leadership qualities including strategic thinking, innovation, mentoring, collaboration, etc Solid working knowledge of drug development process and regulatory requirements [...]
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Job vor 5 Tagen bei NewScientist Jobs gefunden Dyne Therapeutics Senior Director, Regulatory Affairs • Waltham, Massachusetts, United States, Waltham Führungs-/ Leitungspositionen Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE[...]
MEHR INFOS ZUM STELLENANGEBOT[...] collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program s critical regulatory milestones Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management Outstanding communication skills (verbal and written) , regulatory writing skills and willingness to share knowledge and lessons learned #LI-Onsite The statements contained herein reflect general details as necessary [...]
Alle Senior Director Stellenangebote anzeigen
Job vor 5 Tagen bei NewScientist Jobs gefunden Vericel

Director, Regulatory Affairs

 • Burlington, Massachusetts, United States, Burlington Führungs-/ Leitungspositionen At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our[...]
MEHR INFOS ZUM STELLENANGEBOT[...] Previous experience with combination products and/or botanicals a plus. Experience with prescription drug advertising regulations and promotional review committee s Working knowledge of FDA regulations and understanding of FDA structure and function. Working knowledge of eCTD elements and structure. Strong regulatory writing skills and verbal communication skills. Strong team player that has a customer service approach and is solution oriented. Attention to [...]
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Job vor 6 Tagen bei NewScientist Jobs gefunden Vericel Senior Manager, Regulatory Affairs-Biologics • Burlington, Massachusetts, United States, Burlington At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our[...]
MEHR INFOS ZUM STELLENANGEBOT[...] submissions and supportive amendments and supplements. Experience with prescription drug advertising regulations and promotional review committee. Experience with labeling regulations. Working knowledge of FDA regulations and understanding of FDA structure and function. Working knowledge of eCTD elements and structure. Strong regulatory writing skills and verbal communication skills. Strong team player that has a customer service approach and is solution oriented. Attention to [...]
Job vor 9 Tagen bei NewScientist Jobs gefunden Alkermes

Associate Director Regulatory Affairs

 • Waltham, Massachusetts, United States, Waltham Führungs-/ Leitungspositionen Job Description We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Associate Director of[...]
MEHR INFOS ZUM STELLENANGEBOT[...] experience in the biopharma industry, preferably in neurology Experience as primary regulatory author for IND and CTA documents Strong knowledge of FDA, EMA, and ICH regulatory guidelines and eCTD structure Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely Strong team player: the ability to work flexibly in a [...]
Job vor 9 Tagen bei NewScientist Jobs gefunden Dyne Therapeutics Associate Director, Regulatory Affairs • Waltham, Massachusetts, United States, Waltham Führungs-/ Leitungspositionen Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE[...]
MEHR INFOS ZUM STELLENANGEBOT[...] collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program s critical regulatory milestones Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management Outstanding communication skills (verbal and written) , regulatory writing skills and willingness to share knowledge and lessons learned #LI-Onsite The statements contained herein reflect general details as necessary [...]
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Job vor 12 Tagen bei NewScientist Jobs gefunden Moderna, Inc.

Head of Toxicology

 • Cambridge, Massachusetts, United States, Cambridge Führungs-/ Leitungspositionen Sabbaticals The Role At Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative[...]
MEHR INFOS ZUM STELLENANGEBOT[...] when interpreting nonclinical data as it pertains to active clinical pipeline programs. Provide strategic advice to project teams and senior management including evaluation of conclusions and impact of study results on program and clinical/ regulatory strategy. Apply expert scientific and regulatory writing experience when critically reviewing, editing, and authoring submission application documents (INDs, CTAs, BLAs and MAAs) and health authority interaction documents [...]
Alle Toxicology Stellenangebote anzeigen
Job vor 12 Tagen bei NewScientist Jobs gefunden Moderna, Inc. Principal Statistician, CMC Quantitative Science • Norwood, Massachusetts, United States, Norwood Sabbaticals The Role Moderna is seeking an accomplished Principal Statistician to join our Chemistry, Manufacturing, and Controls (CMC) Quantitative Sciences team onsite in Norwood, MA. As[...]
MEHR INFOS ZUM STELLENANGEBOT[...] Exceptional communication skills, both verbal and written Proficiency with Microsoft Office suite (i. e. Word, Excel, Power Point) Here s What You ll Bring to the Table (Preferred Qualifications) Familiarity with GMP quality concepts used in pharmaceutical production and development Regulatory writing experience, including eCTD submissions and response to health authority questions Thorough comprehension of regulatory guidance, including ICH, WHO, USP guidelines [...]
Job vor 13 Tagen bei Neuvoo.com gefunden ACTEGA DS GmbH

Technical Sales Manager Paper Mills EMEA (m/f/d)

 • Bremen We are ALTANA: one group of companies-four divisions: BYK, ECKART, ELANTAS, and ACTEGA. A global leader in specialty chemicals and with myriad opportunities for you[...]
MEHR INFOS ZUM STELLENANGEBOT[...] to 40) , the following qualifications are important for us:Several years of experience in the paper industry, paper and fiber technology or supplier industry Familiarity with the chemical principles of paper manufacturing and surface treatment/ functionalization as well as a regulatory background Knowledge of technical processes in the production and application of finishes and coatings as well as paper manufacturing Expertise in the use of functional coatings in marketable application processes in online applications, ideally also in printing and coating processes Excellent, business fluent English and German in speech and writing as well as good communication and integration skills Willingness to occasionally travel to the Bremen location Strong self-initiative and assertivenessJoy [...]
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Regulatory Writing Jobs werden allgemein der Kategorie Technische Dokumentation / Redaktion zugeordnet.

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