10 Jobs für Regulatory Writing in Mainz
Stellenangebote Regulatory Writing in Mainz Jobs
Job vor 13 Tagen bei Jobleads gefunden
• Mainz, Rheinland- Pfalz
Führungs-/ Leitungspositionen
Mainz, Germany full time Job ID: 11231 About the Role As an Associate Director Scientific/ Medical
Writing, you will play a pivotal role in advancing Bio NTechs mission to revolutionize [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] medicine by ensuring the timely creation of highquality scientific and regulatory documents. Your contributions will directly impact the development and approval of novel therapeutic agents, supporting Bio NTechs efforts to address diseases with high medical needs. Collaborating within a dynamic and innovative environment, you will work closely with crossfunctional teams to maintain excellence in scientific communication. You will join a workplace that [. .. ]
Job am 11.03.2026 bei Jobleads gefunden
• Mainz, Rheinland- Pfalz
Führungs-/ Leitungspositionen
Jobticket
[. .. ] the internal analytical network and external partners in line with the overall analytical strategy You are in charge of defining and aligning the analytical control strategy across [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] departments (e. g. Regulatory Affairs, CMC, Quality) and also ensure that the proposed strategy is in line with health authority guidelines and regulatory requirements Take full ownership of the analytical CMC Module3 package (authoring, review, lifecycle management) A good Match We are looking for an enthusiastic, committed, and visionary individual, ideally with the following [. .. ] as the USP (United States Pharmacopoeia) , and Ph. Eur. (European Pharmacopoeia) Experience with preapproval activities (e. g. PAI, BLA preparation, launch activities) is a plus Fluent English and technical writing skills Experience in working in intercultural, crossfunctional teams Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies Highly motivated and willingness to work in a fastpaced and fastevolving environment Your Benefits Its our priority to support you: Your flexibility: flexible hours [. .. ]
Job am 06.03.2026 bei Jobleads gefunden
• Mainz, Rheinland- Pfalz
Führungs-/ Leitungspositionen
Flexible Arbeitszeiten Jobticket
[. .. ] carbon governance and accounting, and delivering audit-ready disclosures. You will play a key role in shaping our future sustainability reporting architecture under wave two conditions while driving [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] excellence in regulatory compliance and respectful internal stakeholder alignments. This role reports to the Team Lead CSR Performance and Reporting. Your contribution Lead and support Bio NTechs mandatory CSRd/ESRS and EU Taxonomy implementation, including the preparation of integrated management reports and audit-ready sustainability disclosures; develop sustainability reporting architecture serving mandatory compliance and [. .. ] Pharma and/or Biotech Background would be an asset Demonstrated ability in project management, stakeholder alignment, and effective collaboration with auditors and interface departments Executivelevel communication abilities with strong content writing capabilities Experience with SAP Sustainability Control Tower, SAP Green Ledger, SAP Analytics Cloud, and Workiva reporting platform would be an asset Experience managing ESG ratings, specifically ISS ESG and S P CSA, is highly desirable Strong handson mentality with high personal accountability, consistently delivering qualityoriented work under tight deadlines Business [. .. ]
Neu Job heute bei Jooble gefunden
Randstad Professional
• Mainz- Bingen; Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz
Angebote von Zeitarbeitsunternehmen
[. .. ] It s best to apply online right away and secure this job Applications from individuals with disabilities are warmly welcome. Prepare the respective quality CMC documentation in [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] close collaboration with regulatory affairs, local CMC contacts or subject matter experts (e. g. quality control, production, etc. ) On-time delivery of documents and contents aligned with RA CMC processes and templates for existing global pharmaceutical products (i. e. tech documents required for variations, geographical extensions and renewals) Manage the requests and activities [. .. ] production, chemical development, analytical sciences, quality control, quality assurance or regulatory affairs Profound knowledge of worldwide GMP guidelines and preferably regulatory guidelines with regards to CMC Skills in CMC technical writing Proven operational experience in preparation and review of analytical and manufacturing documentation regarding scientific issues Excellent written and spoken English skills Ability to work independently in international/ multi-disciplinary project teams and to decide, prioritize and consolidate multiple tasks and complex issues Autonomous, analytical and organized working style Performance-based [. .. ]
Job gestern bei Jooble gefunden
Biontech
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Mainz, DE
Führungs-/ Leitungspositionen
Your main responsibilities are: Act as Global
Regulatory Lead for assigned development projects and define and execute the Regulatory Strategy from clinical development up to (including) marketing authorization. Define the [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] strategy for regulatory interactions for the assigned projects. Plan, prepare and conduct interactions with national authorities and sovra-national agencies (e. g. MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development incl. market authorization. Define the storyline for regulatory applications and dossiers through product development up to marketing authorization. Coordinate preparation, writing and reviewing of documents and dossiers (e. g. briefing books, IBs, BLA/ MAA) . Contribute to the setup, adjustment and continuous optimization of regulatory processes, systems and interfaces; represent GRA in cross-functional initiatives for process improvement and with collaboration partners Supervision of vendors active in regulatory affairs on behalf [. .. ]
Job gestern bei Jooble gefunden
Biontech
Associate Director CSR Reporting (m/w/d)
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Mainz, DE
Führungs-/ Leitungspositionen
Flexible Arbeitszeiten Jobticket
[. .. ] carbon governance and accounting, and delivering audit-ready disclosures. You will play a key role in shaping our future sustainability reporting architecture under wave two conditions while driving [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] excellence in regulatory compliance and respectful internal stakeholder alignments. This role reports to the Team Lead CSR Performance and Reporting. Your contribution: Lead and support Bio NTech s mandatory CSRd/ESRS and EU Taxonomy implementation, including the preparation of integrated management reports and audit-ready sustainability disclosures Develop sustainability reporting architecture serving mandatory compliance [. .. ] and/or Biotech-Background would be an asset Demonstrated ability in project management, stakeholder alignment, and effective collaboration with auditors and interface departments Executive-level communication abilities with strong content writing capabilities Experience with SAP Sustainability Control Tower, SAP Green Ledger, SAP Analytics Cloud, and Workiva reporting platform would be an asset Experience managing ESG ratings, specifically ISS ESG and S P CSA, is highly desirable Strong hands-on mentality with high personal accountability, consistently delivering quality-oriented work under tight [. .. ]
Job gestern bei Jooble gefunden
Biontech
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Mainz, DE
Führungs-/ Leitungspositionen
Jobticket
[. .. ] related program activities with internal and external stakeholders and driving integration of services, technologies, and capabilities to ensure reaching of program goals Provide state of the art [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] biomarker input in regulatory documents (clinical study reports, IND, BLA documentation) Analyzes, interprets and presents clinical biomarker data and draws scientifically valid conclusions that support and enable decision making Work with a cross-functional team (clinical team, regulatory, diagnostics, preclinical) to ensure the key definitions in clinical translational steps are in agreement with clinical [. .. ] genuine interest and understanding of the science supporting the development programs Excellent, broad communication skills in various interpersonal settings as well as excellent organization skills and attention to details Strong writing skills as demonstrated by authorship of peer-reviewed publications and contributions to regulatory communications (e. g. , briefing documents, clinical trial protocols, marketing authorization applications) Your Benefits: It s our priority to support you: Your flexibility: flexible hours vacation account Your growth: Digital Learning Performance talent development leadership development Apprenticeships [. .. ]
Job gestern bei Jooble gefunden
Biontech
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Mainz, DE
Jobticket
[. .. ] interpretation as well as a good understanding of statistical methods Demonstrated ability to independently plan and execute projects, analyze data, and draw meaningful conclusions Familiarity with clinical [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] trial processes and regulatory requirements for RUO and IVD assays is a plus Excellent organizational, documentation, scientific writing and communication skills, and the ability to work collaboratively in a cross-functional, matrixed environment with internal and external stakeholders Ability to work in a fast-paced and dynamic environment Your Benefits: It s our priority to support you: Your flexibility: flexible hours vacation account Your growth: Digital Learning Performance [. .. ]
Job gestern bei Jooble gefunden
Biontech
Director AS T Projects Strategy
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Mainz, DE
Führungs-/ Leitungspositionen
Jobticket
[. .. ] the internal analytical network and external partners in line with the overall analytical strategy You are in charge of defining and aligning the analytical control strategy across [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] departments (e. g. Regulatory Affairs, CMC, Quality) and also ensure that the proposed strategy is in line with health authority guidelines and regulatory requirements Take full ownership of the analytical CMC Module 3 package (authoring, review, lifecycle management) A good Match: We are looking for an enthusiastic, committed, and visionary individual, ideally with the [. .. ] as the USP (United States Pharmacopoeia) , and Ph. Eur. (European Pharmacopoeia) Experience with preapproval activities (e. g. PAI, BLA preparation, launch activities) is a plus Fluent English and technical writing skills Experience in working in intercultural, cross-functional teams Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies Highly motivated and willingness to work in a fast-paced and fast-evolving environment Your Benefits: It s our priority to support you: [. .. ]
Job gestern bei Jooble gefunden
Biontech
Associate Director Scientific/ Medical Writing
• Regierungsbezirk Rheinhessen- Pfalz; Rheinland- Pfalz Mainz, DE
Führungs-/ Leitungspositionen
As an Associate Director Scientific/ Medical
Writing, you will play a pivotal role in advancing Bio NTechs mission to revolutionize medicine by ensuring the timely creation of high-quality scientific [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] and regulatory documents. Your contributions will directly impact the development and approval of novel therapeutic agents, supporting Bio NTech s efforts to address diseases with high medical needs. Collaborating within a dynamic and innovative environment, you will work closely with cross-functional teams to maintain excellence in scientific communication. You will join a [. .. ]
Häufig gestellte Fragen
Wieviel verdient man als Regulatory Writing pro Jahr?
Als Regulatory Writing verdient man zwischen EUR 50.000,- bis EUR 75.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Regulatory Writing Jobs in Mainz bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 10 offene Stellenanzeigen für Regulatory Writing Jobs in Mainz.
Zu welchem Berufsfeld gehören Regulatory Writing Jobs in Mainz?
Regulatory Writing Jobs in Mainz gehören zum Berufsfeld Technische Dokumentation / Redaktion.
