Regulatory Processes Stellenangebote

Job vor 3 Tagen bei Jobvector gefunden BioNTech SE

Biologist as Regulatory Affairs Manager (m/f/d)

• Cambridge, 02139 Homeoffice möglich [...] writing and reviewing of documents and dossiers (e. g. briefing books, IBs, MAA, variations) as needed. Represent GRA in cross-functional internal initiatives for process improvement and interactions with internal and external stakeholders, including collaboration partners. Set up, adjustand continuly optimization regulatory processes, systems and interfaces Define and oversee oversight plans for vendors active in regulatory affairs on behalf of BioNTech Monitor changes and evolution in the regulatory landscape for relevant cell and gene therapy products and/or relevant product classes; analyze the impact of new regulations on assigned projects; participate in or propose initiatives to influence regulatory landscape. Develop and establish transparent relationships with Regulatory agencies for the assigned projects. Requirements:University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 15+ years of experience in relevant roles/ positions Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities Good understanding of oncology and immunology; experience in supporting cell therapy products through clinical development Knowledge of [...]
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Job vor 3 Tagen bei Jobleads gefunden Head of Regulatory and Quality • Düsseldorf, Nordrhein- Westfalen Führungs-/ Leitungspositionen [...] This role will lead both the operations and the strategy of this department. The ideal person will have a strong cross-functional experience and have a hands-on approach to strategic leadership. You will be tasked with establishing the Quality system and Regulatory processes for the department including CAPA management, Regulatory affairs, complaint management, and Quality management. What will you need? Deep knowledge in [...]
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Job am 30.03.2025 bei Jobleads gefunden

Medical Director/ Lead Medical Director, Nephrology

• Basel, Basel- Stadt Führungs-/ Leitungspositionen Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to[...]

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[...] active role with other Clinical Science Team (CST) members, regulatory and other internal partners/ stakeholders in the completion and submission of regulatory filings and other regulatory documentation; you will provide clinical science information and input for regulatory submissions and other regulatory processes. You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, Asset [...]
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Job am 26.03.2025 bei Jobleads gefunden Medical Affairs Director • Lübeck, Schleswig- Holstein Führungs-/ Leitungspositionen [...] leadership and influencing skills. Good communication and interpersonal skills, engaging effectively with diverse stakeholders. Ability to work across functions, managing by influence in a cross-cultural, multi-site environment. Strong analytical skills, focusing on data-driven decision-making. In-depth knowledge of clinical trial design, regulatory processes, and post-market surveillance requirements specific to medical devices. What We Can Offer You: At Essity, we believe every career is [...]

Neu Job vor 6 Std. bei Jobleads gefunden

Sponsor Dedicated Study Start Up Lead with Finance expertise based in Munich

• Stuttgart, Baden- Württemberg Führungs-/ Leitungspositionen We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation, regulatory processes, and financial management. This is a well-suited role for someone with experience in clinical start-up operations, budget negotiations, and regulatory [...]
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Neu Job vor 6 Std. bei Jobleads gefunden Senior QA/ RA Manager • München, Bayern [...] auditing duties to ensure compliance with quality standards. Assist in the final review and management of SOPs and QM-related documents. Assist with Vendor Assessment, client audits, and subcontractor audits. Manage Technical Documentation for submissions and product changes. Optimize Quality and Regulatory processes and ensure global QA RA compliance. Requirements: Degree in engineering, biomedical, or a related field; a Masters degree or MBA [...]

Job gestern bei Jobleads gefunden

Lead Medical Director Neuroscience

• Zürich Führungs-/ Leitungspositionen Roche is recruiting for a Lead Medical Director to join our neuroscience clinical development team based in Basel headquarters to support the ongoing late-stage development[...]

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[...] potential strategies to resolve such. Taking an active role with other CST members, regulatory and other internal partners/ stakeholders in completing and submitting regulatory filings and other regulatory documentation. Providing clinical science information and input for regulatory submissions and other regulatory processes, including developing label and packaging language. Collaborating with relevant team members and clinical operations to close out clinical studies, secure [...]

Job vor 2 Tagen bei Jobleads gefunden Director Strategy-Vault Regulatory • Frankfurt, Hesse Führungs-/ Leitungspositionen [...] new features and functionality for new and existing customer base Coordinate resources across the customer lifecycle from sales to delivery and beyond Present at industry conferences, leading webinars, and authoring articles for industry publications Requirements 5+ years of experience with regulatory processes and technology for submission document authoring, submission publishing/ validation/ viewing, registration and commitment tracking, and regulatory document archiving 3+ years [...]

Job vor 5 Tagen bei Jobleads gefunden

Manager Regulatory Affairs (m/f/x)

• Zürich [...] effectively in a multinational organization to accomplish results. Be detail-oriented, reliable, well organized, and self-motivated. Proven ability to plan, coordinate, and lead activities simultaneously on multiple projects. Very high ethical standards. Understanding of development and life-cycle management of drugs and regulatory processes including the regulatory requirements and processes. Ability to interact and communicate effectively with regulatory authorities and stakeholders in a multinational [...]

Job vor 8 Tagen bei Jobleads gefunden R D and Pharmacovigilance Compliance Lead • Bulle, Freiburg Führungs-/ Leitungspositionen Make your mark for patients To strengthen our R D and Pharmacovigilance Quality department we are looking for a talented profile to fill the position[...]

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[...] quality activities independently to ensure subject safety and data integrity, complying with regulations, procedures and contractual agreements. Partner or Lead compliance investigations and ensure timely closure of corrective and preventive actions from assigned deviations, audits, and/or change control processes impacting regulatory processes. Escalate issues early and ensure effective risk-based resolution are in place. Leverage internal stakeholders and subject matter experts network to [...]

Job vor 13 Tagen bei Jobleads gefunden

Regulatory Certification Specialist-RFID Reader (m/f/d) Professionally experienced Puchheim n. . .

• Puchheim, Bayern Work-Life-Balance Regulatory Certification Specialist-RFID Reader (m/f/d) Puchheim near Munich Permanent Full-time Regulatory Affairs Tasks Responsibilities: Manage Global Regulatory Approvals : You will oversee the worldwide approval[...]

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[...] : You will work closely with development, product management, and sales teams, providing guidance on regulatory requirements and ensuring alignment across all functions. Ensure Regulatory Compliance and Risk Management : You will proactively identify, evaluate, and mitigate risks related to regulatory processes, ensuring the timely release of compliant products. Monitor and Interpret Industry Standards : You will stay up to date with [...]

Job vor 14 Tagen bei Jobleads gefunden VP, Head EUCAN Regulatory Strategy • Zürich By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application[...]

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[...] Provides RA guidance and support for individual territory regional development activities. Oversees in-license RA activities identified by the Region Business Unit. CORE ELEMENTS RELATED TO THIS ROLE Demonstration of successful submissions/ management for EUCAN, as well as fundamental knowledge of regulatory processes within US and Japan. Outstanding interpersonal, communication and organizational skills are required as this position works cross-functionally with development functions/ [...]
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Job vor 14 Tagen bei Jobleads gefunden

Head of Regulatory Affairs

• Bern Führungs-/ Leitungspositionen [...] University of Berns ARTORG Center for Biomedical Engineering Research invites applications for a highly skilled and experienced Head of Regulatory Affairs to join our dynamic team and lead our regulatory strategy. About the job and key responsibilities: Develop and implement regulatory processes to ensure compliance with local, national, and international regulations. Lead the preparation and submission of regulatory documents. Collaborate with cross-functional [...]
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Job vor 14 Tagen bei Jobleads gefunden VP, Head EUCAN Regulatory Strategy • Zürich [...] Provides RA guidance and support for individual territory regional development activities. Oversees in-license RA activities identified by the Region Business Unit. CORE ELEMENTS RELATED TO THIS ROLE Demonstration of successful submissions/ management for EUCAN, as well as fundamental knowledge of regulatory processes within US and Japan. Outstanding interpersonal, communication and organizational skills are required as this position works cross-functionally with development functions/ [...]

Job vor 14 Tagen bei Jobleads gefunden

Regulatory Program Director-Devices and Combination Product

• Basel, Basel- Stadt Führungs-/ Leitungspositionen [...] regulatory subject matter expert internally and externally to Roche. Provide regular training internally to enhance organizational knowledge and capability. Coach and mentor junior regulatory affairs professionals. Lead or represent Pharma Technical Regulatory (PTR) in device-specific internal initiatives to establish internal regulatory processes and systems. Stay abreast of changing regulatory requirements. Analyze regulations, rules, or guidance documents and communicate potential impact to internal [...]

Job am 03.04.2025 bei Jobleads gefunden Quality Assurance Regulatory Affairs Engineer • Tübingen, Baden- Württemberg Quality Assurance Regulatory Affairs Engineer Focused on DACH Medical Devices R D, Clinical, Quality Regulatory Affairs Quality Assurance Regulatory Affairs Engineer Do you thrive in[...]

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[...] Implement and manage risk management activities (ISO 14971) . Serve as the link between quality assurance, regulatory affairs, and project teams. Requirements Degree in biomedical, electrical, or mechanical engineering (or equivalent) 2+ years of experience in Med Tech quality and regulatory processes Skilled in Technical Documentation (MDR, ISO 13485, IEC 60601-1, ISO 14971) ; FDA experience is a plus Experience with safety [...]

Job am 03.04.2025 bei Jobleads gefunden

Enterprise Risk Manager (gn)

• Frankfurt, Hesse [...] analysis and commentary. Liaise with subject matter experts for quantitative and qualitative information, maintain risk documentation (policies and procedures) , support project management, and monitor regulatory and legal developments for reporting to stakeholders. Requirements: Experience in enterprise risk management and regulatory processes Strong analytical skills for risk data handling and reporting. Ability to support and prepare for risk management committees and processes [...]
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Job am 31.03.2025 bei Jobleads gefunden Head of Global Quality Management Regulatory Affairs Bioprocess (m/w/d) • Jülich, Nordrhein- Westfalen Führungs-/ Leitungspositionen Your challenges The Head of Global Quality Management and Regulatory Affairs Bioprocess is responsible for the strategic and operational Bioprocess Quality Management System and regulatory[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] regulatory submissions to authorities in cooperation with local country/ Regional Regulatory Affairs colleagues Anticipate regulatory obstacles and emerging issues throughout the product lifecycle Monitor validity of licenses, registrations and listings and renew in time Drive the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global Bioprocess QM/ RA group Leadership/ people management Manage efficiently [...]

Job am 30.03.2025 bei Jobleads gefunden

Senior Technical Analyst Risk ESG TA PMT Hybrid/Full remote

[...] ensure alignment with architecture, security, and compliance standards, and drive continuous improvement in software quality and performance. The RISK ESG Group is responsible for the evolution and maintenance of the IT solutions capable of calculating all metrics required by managerial regulatory processes. Operating at the intersection of Risk Environmental Social Governance (ESG) , the team plays a strategic role in delivering high-quality, [...]

Job am 30.03.2025 bei Jobleads gefunden Sponsor Dedicated Study Start Up Lead with Finance expertise based in Munich • Duisburg, Nordrhein- Westfalen Führungs-/ Leitungspositionen We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation, regulatory processes, and financial management. This is a well-suited role[...]

MEHR INFOS ZUM STELLENANGEBOT

We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation, regulatory processes, and financial management. This is a well-suited role for someone with experience in clinical start-up operations, budget negotiations, and regulatory [...]

Job am 30.03.2025 bei Jobleads gefunden Medior Backend Engineer Risk ESG TA PMT Hybrid/Full remote Apply as Medior Backend Engineer Risk ESG TA PMT Hybrid/Full remote General Information Job ID: 34820 Company: Competence Line Digital Country: Job Type: Professional Functional[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] compliance standards, and collaborate with cross-functional teams to evolve the application landscape in the RISK ESG domain. The RISK ESG Group is responsible for the evolution and maintenance of the IT solutions capable of calculating all metrics required by managerial regulatory processes. Operating at the intersection of Risk Environmental Social Governance (ESG) , the team plays a strategic role in delivering high-quality, [...]

Job am 30.03.2025 bei Jobleads gefunden Senior Implementation Consultant-RIMS (Remote) • Frankfurt, Hesse Beratungs-/ Consultingtätigkeiten Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc. Consulting experience, working with a major system integrator or software vendor Regulatory Affairs, Regulatory Operations or Pharmacovigilance background Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content PMP certification Execution experience with Agile methodology and/or ACP Certification Life Science, computer science, or related degree [...]

Job am 27.03.2025 bei Jobleads gefunden Sponsor Dedicated Study Start Up Lead with Finance expertise based in Munich Führungs-/ Leitungspositionen We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation, regulatory processes, and financial management. This is a well-suited role[...]

MEHR INFOS ZUM STELLENANGEBOT

We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation, regulatory processes, and financial management. This is a well-suited role for someone with experience in clinical start-up operations, budget negotiations, and regulatory [...]

Job am 26.03.2025 bei Jobleads gefunden Policy Director (Prudential) Führungs-/ Leitungspositionen Add expected salary to your profile for insights The Australian Banking Association (ABA) The ABA is a dynamic and innovative organisation that works effectively as[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] experience in financial services, ideally banking, and prudential regulation Subject matter experience in banking risk management practices Prudential risk management experience highly desirable Credit risk management, housing, and competition policy knowledge highly desirable Extensive knowledge and experience of political and regulatory processes, media and communications and banking and financial services industry Experience in an area related to regulatory change, legal and compliance [...]

Job am 26.03.2025 bei Jobleads gefunden Manager Medical Affairs (m/f/d) Diabetes Care Austria and Switzerland • Luzern Regional Europe-Canada (EUCAN) Medical Director Respiratory Immunology (R I) Join our industry-leading Bio Pharmaceuticals team, where our rich and diverse pipeline speaks for itself. We[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] Experience in working in an international matrix environment, both in in-market and in above-market roles Profound knowledge of different types of medical evidence and experience in applying it to the portfolio Strong understanding of, and experience with market access and regulatory processes Desirable for the role Qualified Doctor specifically in Immunology and/or Respiratory fields Strong Leadership experience gained through previous line management [...]
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