Head of Late Validation
170k-230k
New York, NY, USA

This ground-breaking biotech that is dedicated to the advancement of RNA therapies targeting chronic liver diseases is actively seeking a Site Head/Head of Late Validation to join their team. This company employs a blend of genomic deep phenotyping, precision RNA medicine, and experimentation utilizing live human donor livers to address significant challenges in liver health, including augmenting donor liver availability and mitigating complications arising from cirrhosis.

 

This company is headquartered out of the UK but has a flagship location in New York City and this role will report directly into the Head of the Research and Development site.

 

Responsibilities:

  • Serve as the Site Head for NYC site and supervise lab staff and manage late-stage validation platforms.
  • Relay regular updates regarding the site and perfusion platform data
  • Manage the perfusion team, lab scientists, and surgical staff
  • Design experimental plans, workflow, and preclinical studies. Work cross-functionally with the Development team to establish workflows for perfusion samples.
  • Partner with recruitment and HR to facilitate hiring and benefit management.

Qualifications

  • PhD in life sciences with 8-10+ years of industry experience
  • Deep understanding of the physiology and human disease biology: specifically, experience with liver disease biology is preferred.
  • Extensive experience in study design for late stage preclinical projects, sample collection and management, as well as analyzing and interpreting datasets.
  • Experience with managing matrixed teams.
Apply
Other roles you might
be interested in:
Regulatory Affairs Manager - DACH (m/f/x)
Baden-Württemberg

Regulatory Affairs Manager - DACH (m/f/x) | Baden - Württemberg Area | Pharmaceutical Industry Are you a regulatory affairs specialist with a knack for navigating the intricacies of marketing authorizations within a global context? Do you excel in adhering to eCTD/eSubmission standards and thrive on contributing to regulatory strategy development? If you're seeking an opportunity to make a significant impact at a well-established medium-sized pharmaceutical company with international reach, your search ends here! Key Responsibilities: Taking care of all local RA activities and deliverables within the D-A-CH countries, including regulatory support for AAA Pharma.Fully responsible for DE/AT/CH exclusive licenses (i.e. maintenance, submissions, texts)Fully responsible for initial creation and maintenance of product information texts in German languageEvaluation and organization of new and updated product registration application dossiers related to the submission procedure, MAH transfers, renewals and variation procedures in DACHEvaluation of content and regulatory quality especially for the administrative documentation (Module 1)Responsible for the complete maintenance and lifecycle management activities of the exclusive licenses in DACHCollaboration with other teams/departments in regulatory affairs relevant projects and assessment of regulatory questionsReview, update, correction and submission of regulatory documentation after receiving the documents from the respective department for the exclusive licenses in DACHParticipation in regulatory affairs related projects regarding developing of new products and supporting TTs for the exclusive licenses in DACHConsistent updating of legislation requirements in DACH region.Excellent knowledge of the technical & regulatory requirements and experience regarding the registration & life cycle management (inter alia tech/site transfers, product information changes, product optimization etc.) of medicinal products with special focus on EU and the D-A-CH countries.At least a basic understanding for the regulatory requirements for food supplements in EU/D-A-CH.Negotiate approaches & responses to health authorities in a manner acceptable to both the regulatory agency and the company demonstrated by a proven track record of ensuring registrations / variations are successfully approved.Management, tracking and prioritization of daily business tasks. Qualifications:Bachelor's or master's degree in pharmacy, (veterinary) medicine, or related natural sciences.Preferably, a Master's in Drug Regulatory Affairs.3+ years of regulatory affairs experience in the pharmaceutical industry or food supplements sector.Strong understanding of registration and lifecycle management activities.Proven experience in negotiating and communicating with regulatory authorities.Proficiency in Regulatory Information Management Systems & Databases.Solid project management skills.Demonstrated reliability, teamwork, initiative, cross-functional collaboration, and multitasking abilities.Excellent written and verbal English; proficiency in German and other languages is advantageous.Benefits:Competitive salary package inclusive of base salary and 13th-month salary.Permanent employment contract.Generous annual leave entitlement of 30 days.Flexible part-time working arrangement (up to 25 hours per week).Convenient accessibility via public transport and ample parking availability.Flexible start date with the option for up to 40-60% remote work. Interested in this Opportunity? If you're eager to leverage your expertise in regulatory affairs within a dynamic pharmaceutical environment, we encourage you to submit your application today! We're also open to considering applications for alternative positions within our organization. My contact details: Email: revesz@sciproglobal.deTel: 0049 (0) 89/ 26 200 311 (direct dial) We eagerly await your application!

Regulatory Affairs Manager - LCM
Stuttgart, Baden-Württemberg

Regulatory Affairs Manager (m/w/d) - LCM | Stuttgart area | Pharma You are an expert for regulatory activities for marketing authorizations in a global environment? Publishing according to eCTD / eSubmission standards is one of your key competencies? You want to play in active part in setting up regulatory strategy? If you are interested in experiencing this at a very well-positioned medium-sized and internationally operating pharmaceutical company, then you have come to the right place! What will your activities as "Regulatory Affairs Manager (m/f/x)" involve? Taking care of all local RA activities and deliverables within the D-A-CH countries, including regulatory support for AAA Pharma.Fully responsible for DE/AT/CH exclusive licenses (i.e. maintenance, submissions, texts)Fully responsible for initial creation and maintenance of product information texts in German languageEvaluation and organization of new and updated product registration application dossiers related to the submission procedure, MAH transfers, renewals and variation procedures in DACHEvaluation of content and regulatory quality especially for the administrative documentation (Module 1)Responsible for the complete maintenance and lifecycle management activities of the exclusive licenses in DACHCollaboration with other teams/departments in regulatory affairs relevant projects and assessment of regulatory questionsReview, update, correction and submission of regulatory documentation after receiving the documents from the respective department for the exclusive licenses in DACHParticipation in regulatory affairs related projects regarding developing of new products and supporting TTs for the exclusive licenses in DACHConsistent updating of legislation requirements in DACH region.Excellent knowledge of the technical & regulatory requirements and experience regarding the registration & life cycle management (inter alia tech/site transfers, product information changes, product optimization etc.) of medicinal products with special focus on EU and the D-A-CH countries in particular.At least a basic understanding for the regulatory requirements for food supplements in EU/D-A-CH.Negotiate approaches & responses to health authorities in a manner acceptable to both the regulatory agency and the company demonstrated by a proven track record of ensuring registrations / variations are successfully approved.Management, tracking and prioritization of daily business tasks.Maintenance of RIMS for allocated products What does the position as "Regulatory Affairs Manager (m/f/x)" offer you? Salary: base salary + 13th salaryContract type: unlimitedVacation: 30 days / yearWorking time: Parttime - up to 25 hoursAccessibility: Very good transport connections by public transport; sufficient parking spaces availableStart date: At the next possible dateLocation: Either in the company HQ in the Stuttgart area or up to 75% remote with 25% on site (around 5 days a month) What requirements should you bring as "Regulatory Affairs Manager (m/f/x)"? Completed studies in pharmacy, (veterinary) medicine or comparable natural sciencesMaster of Drug Regulatory Affairs is an advantage3+ years of professional experience in regulatory affairs in the pharmaceutical industry or Food SupplementsExtensive knowledge in registration & life cycle management activitiesExperience in negotiation / communication with regulatory authoritiesExperience in handling and maintaining Regulatory Information Management Systems & DatabasesExtensive knowledge of project managementReliability, team spirit, initiative, cross-departmental thinking and the ability to manage several projects simultaneouslyVery good written and spoken English; knowledge of German and other languages is an advantageInformation about our customer:Our client is an international pharmaceutical company with about 1000 employees in more than 30 countries. The company has been completely family-owned from the very beginning (founded in 1971) and develops and sells biofactor and generic products. The product range includes prescription drugs as well as OTC products and dietary supplements. As part of a large-scale growth initiative, the company plans to multiply its turnover in the coming years. Does this position appeal to you? Then you should apply now! If you would like to receive further or alternative positions, I would also be pleased to receive your application! I look forward to your application!

(Senior) Manager - Regulatory & Medical Writing (m/w/d)
Freiburg im Breisgau (79098), Baden-Württemberg

Senior Manager - Regulatory & Medical Writing (m/f/x) | Freiburg / hybrid Unser Kunde ist ein familiengeführtes Pharmaunternehmen, das sich auf innovative Arzneimittel im Feld der Gastroenterologie und Hepatologie fokussiert hat. Mit den bestmöglichen Therapien versucht das Unternehmen, die Sicherheit in Alltagssituationen von Betroffenen mit chronischen Darmerkrankungen sowie Stoffwechselprobleme, zu ermöglichen. Welche Aufgaben haben Sie als "Senior Manager - Regulatory & Medical Writing "? Übernahme der Gesamtverantwortung für die Erstellung verschiedener wissenschaftlicher und regulatorischer Dokumente, einschließlich der wissenschaftlichen und inhaltlichen Bewertung sowie der Abstimmung mit Fachabteilungen.Verantwortung für die Erstellung wissenschaftlicher und regulatorischer Dokumente, einschließlich präklinischer und klinischer Module, Orphan Drug Designations, PIPs und Briefing-Dokumente.Regulatorische Betreuung von Entwicklungsprojekten, Fokus auf präklinische und klinische Fragestellungen, PIPs, Orphan Designation und Scientific AdviceZusammenarbeit mit globalen Vertriebspartnern und Tochterunternehmen weltweit bei Neuzulassungen und Lifecycle-Management.Koordination und Umsetzung regulatorischer Tätigkeiten im Pharmakovigilanz-Bereich, z. B. PSUR-Einreichungen.Regulatorische Unterstützung bei Ein- und Auslizensierungsaktivitäten und Entwicklung von Zulassungsstrategien.Company Core Data Sheets (CCDS) o Darauf basierend Erstellung und Aktualisierung der Produktinformationstexte für regulatorische Prozesse (Neuzulassungen, Variations, Renewals etc.)Regulatorische Unterstützung bei Ein- und Auslizensierungsaktivitäten (Due Diligence) und bei der Entwicklung von Zulassungsstrategien Welche Anforderungen sollten Sie als " Senior Manager - Regulatory & Medical Writing " mitbringen? Studium der Pharmazie, Humanmedizin oder in den NaturwissenschaftenLangjährige Berufserfahrungen im Bereich Regulatory Affairs, idealerweise min. 7 JahreErfahrungen als Regulatory Medical Writer (Module 2.5. & 2.7.), sowie Erstellung von PIPsErste Erfahrungen mit Zulassungsverfahren in den USAFundierte Kenntnisse der medizinischen NomenklaturGute Kommunikation - und PräsentationsfähigkeitenTeamfähigkeit und FlexibilitätFließend in Englisch und DeutschFormularbeginn Was bietet Ihnen das Unternehmen?Vertragsart: unbefristeter VollzeitvertragUrlaub: 30 Tage / Jahr + ZusatzurlaubHomeoffice: up to 60% remote / mobilArbeitszeiten: 40 Stunden / WocheZugang: Parkplätze vor Ort und sehr gute Anbindung an öffentliche VerkehrsmittelStarttermin: So bald wie möglich Meine Kontakdaten:Email: inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)Xing: https://www.xing.com/profile/Marlene_Inderhees/cvLinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/ Sind Sie an dieser Stelle interessiert? Dann sollten Sie sich jetzt bewerben! Wenn Sie weitere oder alternative Stellenangebote wünschen, freue ich mich auch über Ihre Bewerbung!Ich freue mich auf Ihre Bewerbung!

Senior Manager Regulatory Affairs Strategy (m/w/d)
Munich, Bayern

Senior Manager Regulatory Affairs Strategy (m/f/x) | Munich area / hybrid The increasing demand for specialized knowledge related to our European operations has necessitated the creation of a new position in one of our European offices, including Germany. This role, positioned at the Senior level, will be independent working and leadership in direct interactions with EU Regulatory and with business partners. The primary focus will be supporting development activities and managing teams. What will your tasks as "Senior Manager Regulatory Affairs Strategy (m/f/x)" be?Develop regulatory strategy aligned with company goalsOversee design of clinical studiesCoordinate preparation, submission, and tracking of study and regulatory applications in EU and USAManage medical writing and ensure compliance with relevant laws and regulationsLead and develop Regulatory Affairs and Drug Development teamCoordinate collaboration with external service providers involved in the study and the marketing authorization process, in particular CROs.Regularly present project progress and status to leadership team and executive managementResponsible for developing the regulatory strategy to achieve our regulatory goals in line with the company's objectives.Work closely with other departments, such as Quality Assurance, to achieve regulatory objectives. Your requirements as "Senior Manager Regulatory Affairs Strategy (m/f/x)"?Degree within a scientific field5+ years' experience in regulatory affairs, with a primary focus on guiding products through the clinical development process.Experience in managing and developing staff members is desirable.Familiarity with interactions with the EU & FDAPreferred experience in shaping EU regulatory strategiesAbility to negotiate and concisely express clear positions to stakeholders at all organizational levels.Direct experience in working with national regulatory agencies and leading face-to-face agency meetings.Business-fluent written and spoken in English and German What does the role as "Senior Manager Regulatory Affairs Strategy (m/f/x)" offer to you?Depending on previous experience, there is a chance to specialize more towards the Development or Commercial site of the clients pipeline.Hybrid working model with 40% home office possible.New position: New know-how and strong team players needed 😊30 Days of holiday Information about our client:The company is an international healthcare incubator active in various areas such as intelligent bacteria, innovative pain therapies, chemical-free drugs, medical cannabis and rare diseases, works with over 20 companies and has more than 70 drug approvals.Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application! My contact details:Email: m.inderhees@sciproglobal.de Tel: 0049 (0) 89/26 20 09 25 (direct dial) I look forward to your application!

(Senior) Manager - Regulatory & Medical Writing (m/w/d)
Freiburg im Breisgau (79098), Baden-Württemberg

Senior Manager - Regulatory & Medical Writing (m/f/x) | Freiburg / hybrid Unser Kunde ist ein familiengeführtes Pharmaunternehmen, das sich auf innovative Arzneimittel im Feld der Gastroenterologie und Hepatologie fokussiert hat. Mit den bestmöglichen Therapien versucht das Unternehmen, die Sicherheit in Alltagssituationen von Betroffenen mit chronischen Darmerkrankungen sowie Stoffwechselprobleme, zu ermöglichen. Welche Aufgaben haben Sie als "Senior Manager - Regulatory & Medical Writing "? Übernahme der Gesamtverantwortung für die Erstellung verschiedener wissenschaftlicher und regulatorischer Dokumente, einschließlich der wissenschaftlichen und inhaltlichen Bewertung sowie der Abstimmung mit Fachabteilungen.Verantwortung für die Erstellung wissenschaftlicher und regulatorischer Dokumente, einschließlich präklinischer und klinischer Module, Orphan Drug Designations, PIPs und Briefing-Dokumente.Regulatorische Betreuung von Entwicklungsprojekten, Fokus auf präklinische und klinische Fragestellungen, PIPs, Orphan Designation und Scientific AdviceZusammenarbeit mit globalen Vertriebspartnern und Tochterunternehmen weltweit bei Neuzulassungen und Lifecycle-Management.Koordination und Umsetzung regulatorischer Tätigkeiten im Pharmakovigilanz-Bereich, z. B. PSUR-Einreichungen.Regulatorische Unterstützung bei Ein- und Auslizensierungsaktivitäten und Entwicklung von Zulassungsstrategien.Company Core Data Sheets (CCDS) o Darauf basierend Erstellung und Aktualisierung der Produktinformationstexte für regulatorische Prozesse (Neuzulassungen, Variations, Renewals etc.)Regulatorische Unterstützung bei Ein- und Auslizensierungsaktivitäten (Due Diligence) und bei der Entwicklung von Zulassungsstrategien Welche Anforderungen sollten Sie als " Senior Manager - Regulatory & Medical Writing " mitbringen? Studium der Pharmazie, Humanmedizin oder in den NaturwissenschaftenLangjährige Berufserfahrungen im Bereich Regulatory Affairs, idealerweise min. 7 JahreErfahrungen als Regulatory Medical Writer (Module 2.5. & 2.7.), sowie Erstellung von PIPsErste Erfahrungen mit Zulassungsverfahren in den USAFundierte Kenntnisse der medizinischen NomenklaturGute Kommunikation - und PräsentationsfähigkeitenTeamfähigkeit und FlexibilitätFließend in Englisch und DeutschFormularbeginn Was bietet Ihnen das Unternehmen?Vertragsart: unbefristeter VollzeitvertragUrlaub: 30 Tage / Jahr + ZusatzurlaubHomeoffice: up to 60% remote / mobilArbeitszeiten: 40 Stunden / WocheZugang: Parkplätze vor Ort und sehr gute Anbindung an öffentliche VerkehrsmittelStarttermin: So bald wie möglich Meine Kontakdaten:Email: inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)Xing: https://www.xing.com/profile/Marlene_Inderhees/cvLinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/ Sind Sie an dieser Stelle interessiert? Dann sollten Sie sich jetzt bewerben! Wenn Sie weitere oder alternative Stellenangebote wünschen, freue ich mich auch über Ihre Bewerbung!Ich freue mich auf Ihre Bewerbung!

banner

Need more help? Reach out<br></br> to one of our team.

We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.