Regulatory Affairs Manager
Vor 4 Tagen
Fulltime
Vienna
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a Regulatory Affairs Manager (f/m/d).
About the Role: In this role you are responsible for the development and implementation of regulatory strategies to ensure successful registrations and product launches for AOP Health products.
**What Your Day To Day Will Look Like**:
- You will be responsible for preparing and compiling registration dossiers according to country specific requirements in collaboration with other functions.
- Compile high quality eCTD sequences as required in the eCTD publishing tool Coordinate, review and proof-read responses to questions from authorities
- Evaluate changes for regulatory impact and filing requirements
- Ensure regulatory compliance by maintaining relevant data and documents in the Regulatory Database and Document Management System
- You report to stakeholders, including communication of approvals, worldwide marketing authorization status and other relevant information from Regulatory Databases
- You will play a key role in the submission management of new regulatory projects and in the life cycle management of existing licenses (EU and non-EU scope)
- Provide regulatory guidance and strategy to project teams involved in new product development
- Develop global regulatory strategy for assigned product(s) including submission strategy, timelines, recommendations regarding expansion plans and country requirements etc.
- Manage payments for regulatory procedures and annual fees
- Act as regulatory contact person for authorities, external partners and in-house functions
- Provide regulatory advice on proposed changes to life cycle management and pharmaceutical development activities
- Manage projects within the department as well as interdepartmental projects
**Your Qualifications and Experience**:
- University degree in Natural Science
- At least 3-year RA experience in the pharmaceutical industry in an international environment In-depth knowledge of international regulatory requirements
- Ability to strategically plan, prioritise and manage multiple projects
- Attention to details and ability to deliver high quality regulatory documentation and submissions
- Solution-oriented way of working
- Strong communication skills to liaise with internal and external partners with different cultural backgrounds
- Full proficiency in MS Office, knowledge of SharePoint and an eCTD publishing tool is a plus
- Fluent in English and German, any other language is a plus
**Our offer**:
- A position with personal responsibility and space for creativity
- Open corporate culture with the opportunity to bring in your own ideas
- Highly motivated, agile, and international team
- Great opportunities for personal and professional development
- Attractive work environment with excellent career opportunities and flat hierarchies
- Competitive salary package plus bonus and various benefits
- Gross monthly salary provided for this function is a minimum of EUR 3.800. based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative",
**Main Benefits.**:
**Previous slide**
**Next slide**
**01**
**Bonus**:
Yearly Bonus.
**02**
**Homeoffice**:
Take your focus when needed and stay connected.
**03**
**Mobile Phone**:
Employee mobile phone
**04**
**Flexibility**:
Flexible working hours
**05**
**Laptop**:
Company laptop
**06**
**Education**:
Job training and further education
**07**
**Canteen**:
Canteen on premises
**08**
**Transportation**:
Good connection to public transportation
**09**
**Events**:
Afterwork, Team and All-Company events
**10**
**Doctor**:
Company doctor
**11**
**Parking**:
Parking spot
**Your Contact.**:
**Kathrin Breuer, BA, MA**
**.**
**com**
**Kathrin Breuer, BA, MA**
**HR RECRUITER**
We’re committed to the highest standards of integrity, transparency, and accountability. We value the trust of our business associates, prospective partners, media, and interested parties who are not yet familiar with AOP Health.
-
Regulatory Affairs Operations Professional
Vor 6 Tagen
Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG VollzeitWelcome to Boehringer Ingelheim RCV GmbH & Co KG, where we develop breakthrough therapies and innovative healthcare solutions. As a family-owned company, we focus on long-term performance and believe that talented individuals can drive success.We are seeking a Regulatory Affairs Operations Manager to join our team in Vienna for 12 months. This role requires...
-
Associate Director, Regulatory Affairs
vor 4 Wochen
Wien, Österreich Jobleads VollzeitJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market Surveillance Job Type: Full Time, Permanent Position Locations: Austria, Vienna – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
-
Regulatory Affairs Operations Specialist
vor 1 Woche
Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG VollzeitAt Boehringer Ingelheim, we strive to deliver innovative solutions in areas of unmet medical need. As a family-owned company, our long-term focus allows us to invest in talented individuals who drive growth and success. With 50,000 employees worldwide, we foster a diverse, collaborative culture that values innovation and ambition.Job OverviewWe are seeking a...
-
Regulatory Affairs Operations Director
vor 1 Woche
Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG VollzeitAbout the RoleWe are seeking a highly skilled Regulatory Affairs Operations Manager to join our team in RCV, Vienna. This is a 12-month contract role that requires a dynamic individual with strong expertise in clinical development, clinical trial applications, and regulatory affairs.
-
Associate Director, Regulatory Affairs
vor 1 Monat
Wien, Österreich Cpl Healthcare VollzeitJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocations: Austria, Vienna - HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due...
-
Junior Group Regulatory Affairs Manager
vor 7 Monaten
Wien, Österreich Raiffeisen Bank International Vollzeit**Junior Group Regulatory Affairs Manager** **Prudential Topic (f/m/x)**: - The Group Supervisory Affairs & Regulatory Governance Unit is a well-established department within the Group Regulatory Affairs division, is a single point of contact (SPOC) towards European and Austrian banking supervision authorities, manages the supervisory review and evaluation...
-
Regulatory Affairs Operations Specialist
vor 3 Wochen
Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG VollzeitAt Boehringer Ingelheim RCV GmbH & Co KG, we are seeking a highly skilled Regulatory Affairs Operations Manager to join our team in Vienna. This is a 12-month limited contract opportunity.About the PositionWe require an experienced professional with a strong background in clinical development, clinical trial applications, and regulatory affairs. The...
-
Regulatory Affairs Operations Specialist
vor 4 Wochen
Wien, Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG VollzeitBoehringer Ingelheim RCV GmbH & Co KG seeks a highly skilled Regulatory Affairs Operations Manager to join our team in Vienna for a limited contract period of 12 months.About the RoleThe ideal candidate will have proven experience in clinical development, clinical trial applications, and regulatory affairs. They should be able to manage and lead projects...
-
Regulatory Affairs Manager
vor 2 Wochen
Wien, Österreich AOP Orphan Vollzeit**Professional Skills**: - University degree in Natural Science - At least 2-year Regulatory Affairs experience in the pharmaceutical industry in an international environment - In-depth knowledge of international regulatory requirements - Ability to strategically plan, prioritise and manage multiple projects - Attention to details and ability to deliver...
-
Regulatory Affairs Manager
vor 7 Monaten
Wien, Österreich globe personal services GmbH VollzeitGlobe personal services verbindet hochqualifizierte Fachkräfte sowie Experten mit ihren zukünftigen Arbeitgebern. Menschen und ihre Gesundheit stehen für unseren Kunden im Vordergrund. Um dies weiterhin gewährleisten zu können, benötigt das Pharma-Unternehmen Verstärkung im Bereich Regulatory Affairs. Regulatory Affairs Manager (m/w/d) **Ihre...
-
Head of Regulatory Affairs
vor 3 Monaten
Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit**The position**: As of now we are seeking a Head of Regulatory Affairs & Pharmacovigilance for our Animal Health RCV (Regional Center Vienna) department to join at Boehringer Ingelheim´s site in Vienna. In this role you will be responsible for managing the Product Registration Chain, Compliance with all regulatory authorities and Global Regulatory Affairs,...
-
Wien . Bezirk (Innere Stadt), Österreich Allergopharma GmbH & Co. KG VollzeitWir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Abteilung bei Allergopharma GmbH & Co. KG leiten und weiterentwickeln möchte.Über unser UnternehmenAllergopharma ist ein internationales Pharmaunternehmen mit Sitz in Reinbek. Wir sind spezialisiert auf die Entwicklung, Herstellung und den Vertrieb von Präparaten zur Diagnose und Therapie...
-
Junior Group Regulatory Affairs Manager
vor 7 Monaten
Wien, Österreich Raiffeisen Bank International Vollzeit**Junior Group Regulatory Affairs Manager** **Payments Topic (f/m/x)**: - The Group Supervisory Affairs & Regulatory Governance Unit is a well-established department within the Group Regulatory Affairs division, acts as a regulatory Hub responsible for monitoring EU, international and national regulatory landscape for all regulatory developments which are...
-
Regulatory Affairs Project Manager
vor 5 Monaten
Wien, Österreich Perrigo Vollzeit**Description Overview**: Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. We are looking for the following: Regulatory Affairs Project Manager DACH (m/w/d) Based in Vienna or Remote Reporting Line: Senior Regulatory Affairs Manager...
-
Regional Regulatory Affairs Manager
vor 15 Stunden
Wien, Österreich Boehringer Ingelheim VollzeitRegional Regulatory Affairs Manager (m/w/d) -222123 **THE POSITION** As of now we are seeking a Regulatory Affairs Manager RCV (RA Regional Center Vienna) to join our Medicine Department at BI’s site in Vienna. The focus of the position will be to implement BI Global/RCV and Local regulatory affairs strategy and perform RA activities for allocated...
-
Professional Group Regulatory Affairs Manager
vor 1 Monat
Wien, Österreich Raiffeisen Bank International AG Vollzeit-Search by Keyword - Show More Options _ - Loading... _ - Select how often (in days) to receive an alert: _ - Create Alert _ **_Professional Group Regulatory Affairs Manager (f/m/x) _**: - Elevate your career by joining our Group Supervisory Affairs & Regulatory Governance department as a Professional Group Regulatory Affairs Manager. In this influential...
-
Regulatory Affairs Project Manager
vor 9 Monaten
Wien, Österreich Perrigo Company Vollzeit**Description Overview**: Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. We are looking for the following: Regulatory Affairs Project Manager DACH (m/w/d) Based in Stuttgart, Vienna or Remote Reporting Line: Senior Regulatory...
-
Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG VollzeitAbout Boehringer Ingelheim RCV GmbH & Co KGWe are a family-owned company with a long history of developing breakthrough therapies and innovative healthcare solutions in areas of unmet medical need, both for humans and animals.Our diverse, collaborative, and inclusive culture is built on the strengths of over 50,000 employees globally. This unique environment...
-
Regulatory Affairs Manager in
vor 7 Monaten
Wien, Österreich Talentor Sweden AB VollzeitUnser Klient ist ein eigentümergeführtes, pharmazeutisches Unternehmen, das weltweit verschreibungspflichtige Originalpräparate für Fachärzt*innen anbietet, weiterentwickelt und über strategische Zukäufe stetig wächst. Über seine Zentrale in Wien wird sein etabliertes Netzwerk zur Herstellung und zum Vertrieb seiner Produkte gesteuert. Das...
-
Leiter/in Regulatory Affairs mit Führungserfahrung
vor 4 Wochen
Wien, Wien, Österreich Talentor Austria GmbH VollzeitUnser Kunde ist ein namhaftes pharmazeutisches Unternehmen, das weltweit hochwertige Arzneimittel für Fachärzte entwickelt, produziert und vertreibt. Es verfügt über eine umfassende Erfahrung in der Durchführung klinischer Studien und hat sich auf die Erbringung von hochqualitativen Dienstleistungen spezialisiert.Beschreibung der PositionWir suchen...
