Regulatory Affairs Manager
vor 1 Monat
The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide Regulatory Consulting for ODS Applications, New Marketing Authorisation Applications, as well as Swiss variation and PSUR submissions.
Key Responsibilities/Scope of the Job
Manage client's product portfolio
Prepare the Swiss submissions based on applications submitted in EU or elsewhere including all documents
needed for inclusion in module 1 of the eCTD. Perform a quality check on the documentation for suitability for submission to Swissmedic (validation according to Swissmedic requirements).
Create/update the Swiss Product Information (Information for Professionals and Patient Information as applicable) based on the SmPC approved in the EU or elsewhere.
Prepare module 1 documents (forms, locally required documents etc.) based on the documentation provided by Company (e.g., module 1 from the EU submission). Indicate sufficient hyperlinking for Swissmedic purposes.
Perform/Support submissions activities to Swissmedic through the appropriate electronic gateway and support client during the entire regulatory process.
Establish and maintain contact with the national regulatory authorities (Swissmedic) on behalf of client
Assist client's in national regulatory affairs issues and provide advice on national-specific requirements related to clients product(s)
Monitor national Regulatory Affairs legislation and continuously inform client of new or changed national requirements that affect client's products
Advise client on current Swissmedic requirements for packaging materials.
Co-ordinate end to end local activities including artwork and proof reading
aRMM submissions, adaptation, and maintenance (translation)
Update product information to relevant local HA databases
Position Qualifications
Education/Learning Experience/Work Experience
A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance)
Experience of regulatory requirements in countries outside the US and Europe
Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset
Experience from leading projects and cross-functional teams
German language on B2/C1 level
Personal Attributes
A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds
Highly self-motivated and able to drive activities
Excellent communication skills
The suitable candidate should demonstrate the values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership
Ensure exemplary behavior, ethics and transparency within the Company and with regulatory agencies
#LI-Remote
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Regulatory Affairs Manager
vor 6 Stunden
Frankfurt, Deutschland Biocon Biologics VollzeitAbout the company:At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We have a long-term...
-
Regulatory Affairs Manager
vor 1 Woche
Frankfurt, Deutschland Hays VollzeitIhre AufgabenSteuerung des gesamten regulatorischen Prozesses - von der ersten Idee über die strategische Ausrichtung bis hin zum Markteintritt des ProduktsEvaluierung von Innovationen und Lizenzprodukten im Bereich der stofflichen MedizinprodukteImplementierung der Vorgaben der Medizinprodukte-Verordnung (MDR) und des Medizinprodukte-Durchführungsgesetzes...
-
Frankfurt, Deutschland Real Staffing VollzeitEin spannendes Unternehmen aus Hessen sucht zum nächstmöglichen Eintrittstermin einen Director (m/w/d) Regulatory Affairs & Quality Management in unbefristeter Festanstellung. Ihr Aufgabengebiet:Entwicklung und Leitung wettbewerbsfähiger und innovativer Regulierungsstrategien und Sicherstellung der Einhaltung der Vorschriften während des gesamten...
-
EMEA HR Regulatory Affairs
vor 1 Monat
Frankfurt, Deutschland JPMorgan Chase & Co. VollzeitYou will be part of the Europe, Middle East, and Africa (EMEA) HR Regulatory Affairs team overseeing aspects of regulatory initiatives impacting the Firm’s legal entities in the European Union, including interpretation and implementation of financial regulations impacting across the employee lifecycle, as well as regulatory submissions, exams and...
-
Regulatory Affairs Specialist
Vor 3 Tagen
Frankfurt am Main, Deutschland Deutsche Börse Vollzeit**Learn. Develop. Grow. But always: Share value**: Join our international team that drives positive change, united by a spirit of openness and curiosity. We empower you to have an impact and to grow - personally and professionally. With us, you work at the heart of financial systems and evolve the way markets operate. We’re excited about the future because...
-
Student Regulatory Affairs, Emea
vor 1 Monat
Frankfurt am Main, Deutschland INEOS Styrolution America LLC VollzeitSUCCEED. IN OUR EXPERIENCED TEAM. - INEOS Styrolution ist der weltweit führende Anbieter von Styrolkunststoffen mit Schwerpunkt auf Styrolmonomer, Polystyrol, Standard ABS, und Spezialkunststoffen. Mit erstklassigen Produktionsstätten und mehr als 90 Jahren Erfahrung verhilft INEOS Styrolution seinen Kunden mit bestmöglichen innovativen und nachhaltigen...
-
Referent Regulatory Affairs
Vor 6 Tagen
Frankfurt am Main, Deutschland KfW IPEX-Bank GmbH VollzeitWerden Sie Teil unseres Teams in **Frankfurt am Main** und unterstützen Sie uns als **Referent Regulatory Affairs (w/m/d)**: **Wir bieten facettenreiche Aufgaben**: - In **Regulatory Affairs **agieren Sie als** Hauptansprechpartner** im Dialog mit den** Aufsichtsbehörden** und **beraten** **Kolleg:innen und Führungskräfte** im Umgang mit den...
-
Emea HR Regulatory Affairs
vor 1 Monat
Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit**JOB DESCRIPTION** You will be part of the Europe, Middle East, and Africa (EMEA) HR Regulatory Affairs team overseeing aspects of regulatory initiatives impacting the Firm’s legal entities in the European Union, including interpretation and implementation of financial regulations impacting across the employee lifecycle, as well as regulatory submissions,...
-
Compliance, Regulatory Affairs, Analyst, Frankfurt
vor 2 Wochen
Frankfurt, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm’s culture of compliance. Compliance accomplishes these through the firm’s enterprise-wide compliance risk management program. As an independent control function and part of the firm’s second line of...
-
Junior Expert
vor 1 Monat
Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit**Junior Expert (m/w/d) Regulatory Affairs - Labeling** Innerhalb von Fresenius Medical Care hat Regulatory Affairs die Hauptverantwortung dafür, dass das Unternehmen seine Zulassungen für Medizinprodukte und Arzneimittel erhält und aufrechterhält. Tragen Sie Ihren Teil dazu bei und sorgen Sie für die perfekte Aufmachung eines interessanten...
-
Frankfurt am Main, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance. Compliance accomplishes these through the firm's enterprise-wide compliance risk management program. As an independent control function and part of the firm's second...
-
Frankfurt am Main, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance. Compliance accomplishes these through the firm's enterprise-wide compliance risk management program. As an independent control function and part of the firm's second...
-
Frankfurt am Main, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance. Compliance accomplishes these through the firm's enterprise-wide compliance risk management program. As an independent control function and part of the firm's second...
-
Frankfurt am Main, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance. Compliance accomplishes these through the firm's enterprise-wide compliance risk management program. As an independent control function and part of the firm's second line...
-
Frankfurt, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm’s culture of compliance. Compliance accomplishes these through the firm’s enterprise-wide compliance risk management program. As an independent control function and part of the firm’s second line of...
-
Frankfurt, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm’s culture of compliance. Compliance accomplishes these through the firm’s enterprise-wide compliance risk management program. As an independent control function and part of the firm’s second line of...
-
Working Student
Vor 3 Tagen
Frankfurt am Main, Deutschland Deutsche Börse Vollzeit**Learn. Develop. Grow. But always: Share value**: Join our international team that drives positive change, united by a spirit of openness and curiosity. We empower you to have an impact and to grow - personally and professionally. With us, you work at the heart of financial systems and evolve the way markets operate. We’re excited about the future because...
-
Frankfurt, Deutschland Goldman Sachs VollzeitThe Executive Office plays an integral role in setting and advancing Goldman Sachs’ corporate strategy, and in preserving the firm’s distinctive culture. We are responsible for safeguarding the firm’s relationship with alumni, clients, shareholders, policy makers, and the broader public, while ensuring that our own people remain informed about the...
-
Frankfurt am Main, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance. Compliance accomplishes these through the firm's enterprise-wide compliance risk management program. As an independent control function and part of the firm's second...
-
Frankfurt am Main, Deutschland Goldman Sachs VollzeitOUR IMPACT Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance. Compliance accomplishes these through the firm's enterprise-wide compliance risk management program. As an independent control function and part of the firm's second...
