Regulatory Affairs Manager
vor 3 Monaten
Möchten Sie in einem internationalen Team mitarbeiten, um die Zukunft der Gesundheitsversorgung zu verbessern? Möchten Sie das Leben von Millionen von Menschen verbessern? Grifols ist ein globales Gesundheitsunternehmen. Seit seiner Gründung 1909 in Barcelona arbeitet Grifols daran, die Gesundheit und das Wohlbefinden von Menschen auf der ganzen Welt zu verbessern. Unsere Geschäftsbereiche entwickeln, produzieren und vermarkten innovative Arzneimittel, Lösungen und Dienstleistungen in mehr als 100 Ländern und Regionen.
Regulatory Affairs Manager (m/w/d)
Standort Frankfurt
Die Stelle untersteht dem Technical Director ist in MS 2 eingruppiert.
Der Regulatory Affairs Manager unterstützt den Technical Director bei der Entwicklung und Umsetzung des strategischen Plans im Bereich Regulatory Affairs. Der Regulatory Affairs Manager wird die Hauptverantwortung für europaweite Lizenzen und deren Pflege tragen, um zeitnahe Genehmigungen zu gewährleisten in Übereinstimmung mit den Geschäftszielen von Grifols in Europa.
Bei Eignung ist der/die Inhaber/in der Stelle auch als Informationsbeauftragter gemäß § 74 a Arzneimittelgesetz (AMG) tätig und ist dann verantwortlich für die Sicherstellung der Einhaltung des Täuschungsverbots nach § 8 Abs. 1 Nr. 2 (AMG) sowie dafür, dass die Kennzeichnung, Packungsbeilage und Informationen und Werbematerialien für die Fachkreise dem Inhalt der Zulassung entsprechen.
Verantwortungsbereich:
Manager Regulatory Affairs:
Koordinieren der Aufrechterhaltung der europäischen Marktzulassung und das regulatorische Lebenszyklusmanagement der zugewiesenen Produkte. Erstellung der regulatorischen Dokumentation in Zusammenarbeit mit Kollegen in der Grifols-Zentrale und/oder an den Produktionsstandorten in enger Zusammenarbeit mit RA Biopharma. Koordinieren der Zusammenstellung und Freigabe von Produktinformationen und Packmaterialien gemäß den nationalen und europäischen Gesetzen und Vorschriften für die zugeordneten Produkte. Zusammenarbeit mit Global Regulatory Affairs, Pharmacovigilance, Local Quality und Medical Affairs bei der Vorbereitung und Einreichung der erforderlichen Unterlagen. Überprüfung von Werbematerialien (GRP) und stellt die Einhaltung der einschlägigen europäischen und nationalen Vorschriften und Richtlinien sicher.Informationsbeauftragter:
Überprüfung, ob die wissenschaftlichen Informationen über das Arzneimittel dem aktuellen Stand der Zulassung entsprechen. Kontrollieren und genehmigen der Mock-Ups von neuem Verpackungsmaterial (Etikettierung und Packungsbeilage), um sicherzustellen, dass diese mit den autorisierten Produktinformationen übereinstimmen. Kontrolle und Genehmigung von Werbemitteln im Hinblick auf das Täuschungsverbot (§ 8 Abs. 1 Nr. 2 und § 3 HWG).Anforderungsprofil:
wissenschaftlicher Hintergrund, abgeschlossener Hochschulabschluss im Bereich Life Science (z. B. Master in Pharmazie, Biologie, Chemie, oder ein anderer vergleichbarer wissenschaftlicher Abschluss mindestens 4 Jahre Erfahrung im europäischen pharmazeutischen Regulatory Affairs, idealerweise in biologischen Produkten / aus Plasma gewonnenen Produkten fließende Deutsch- und Englischkenntnisse, weitere Sprachen sind von Vorteil gute Kenntnisse der deutschen nationalen und EU-regulatorischen Anforderungen und Gesetze Erfahrung mit eCTD und entsprechenden Tools wünschenswert Qualifikation als Informationsbeauftragter nach §74a AMG ist wünschenswert Teamorientiert und motiviert sowie in der Lage, Prioritäten für verschiedene Aufgaben zu setzen sehr gute Kommunikationsfähigkeiten, schriftlich wie mündlich Analytische, strukturierte, sorgfältige und gründliche Arbeitsweise gute EDV-Kenntnisse (MS Office und RA-bezogene Software)____________
Regulatory Affairs Manager
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We are looking for a Regulatory Affairs Manager to support the Technical Director in the development and implementation of the strategic regulatory plan. The role will have primary responsibility for European wide registrations and license maintenance to ensure timely approvals in alignment with Grifols European business objectives. If (or when) qualified the position will also serve as the Information Officer according to § 74 a German Drug Act (AMG), who is responsible for ensuring compliance with the prohibition concerning deception as described in § 8 sub-section 1 No. 2 (AMG) and ensuring that the labelling, package leaflets, professional information and advertisements correspond with the content of the marketing authorization.
What your responsibilities will be
You will have the opportunity to:
Coordinate European Marketing Authorization maintenance and regulatory life cycle management of assigned products. Prepare regulatory documentation in collaboration with colleagues at Grifols Headquarters and/or manufacturing sites in close cooperation with RA Biopharma. Coordinate submission of these dossiers to the appropriate regulatory authorities (e. g. Paul-Ehrlich-Institut/PEI or Bundesinstitut für Arzneimittel und Medizinprodukte/BfArM in Germany or EMA) and distribution to external RA partners in the concerned countries as needed. Coordinate compilation of product information according to national and European laws and regulations for the products assigned. Coordinate and contribute to label development and release of packaging materials. Serve as the product primary contact with PEI/BfArM or other competent authorities to ensure the licensing and maintenance of product(s) marketing authorization(s). Coordinate the timely preparation and submission of national documentation for (purely) nationally marketing authorizations, including responses to questions from regulatory authorities. Collaborate with Global Regulatory Affairs, Pharmacovigilance, local Quality and Medical Affairs in the preparation and submission of required documentation. Support maintaining regulatory intelligence database regarding national and EU regulatory requirements through review of publications, attendance at seminars and direct communication with outside regulatory personnel, including regulatory authorities. Participate in review of promotional materials (GRP) and ensures compliance with European regulations and guidelines. Support conduct of authority meetings (e. g. scientific advice). Attend seminars and industry trade association meetings, and where appropriate, serves as company representative on committees and task forces.Information Officer:
Verify that the scientific information about the medicinal product complies with the current status of the marketing authorization. Control and approve the mock-ups of new packaging material (labeling and package insert) to ensure that it is the agreement with the authorized product information. Release the new/updated SmPC (Fachinformation) for publication and distribution and blocks the old superseded SmPC. Control and approve the promotional material with regard to the prohibition concerning deception (§ 8 sub-section 1 No. 2 and § 3 German Drug Advertisement Act (HWG)). Responsible for compilation and revision of SOPs describing the release procedures.Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
You have a University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar). A Master’s Degree is also required. You have at least 4 years of relevant experience in European pharmaceutical Regulatory Affairs, ideally in biological products / plasma derived products. You have good knowledge of German national and EU regulatory requirements and laws. You have experience with eCTD and respective tools desirable. You have a qualification as Information Officer according to §74a AMG (desirable). You possess good computer skills (MS Office and RA related software). You possess good communication and organization skills. You are a structured, diligent, self-motivated and results-oriented person, with high attention to detail. You are a team player, able to collaborate with cross functional teams to achieve the objectives. You speak fluent German and English.What we offer
It’s a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.
Information about Grifols is available at . If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.
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