Regulatory Affairs Manager
Vor 7 Tagen
**Regulatory Affairs Manager (temporary contract for 10 months)**
location: Baar, Switzerland
**Introduction to Role**:
Are you ready to innovate and realize the ambitions in our leading Oncology area? Join our Oncology Business Unit, which is leading the business growth of our enterprise and ever-evolving industry. It’s an exciting time to join as we work towards our ambitions with entrepreneurial thinking and innovation. It’s up to us to find solutions and act fast to make them happen.
**Accountabilities**:
As a Regulatory Affairs Manager, you will work closely with the cross-functional brand teams. You will support the development of regulatory submission strategies and focus on lifecycle management activities. Your support will be pivotal in enabling timely approvals with helpful wording in the product information as supported by clinical and scientific data and in accordance with regulatory guidelines and business/commercial needs.
**Crucial Skills/Experience**:
- ** Education in natural science (MA or PhD)**:
- Profound digital literacy, especially using office programs
- Communication and negotiation skills
- Interpersonal ability
- Solution oriented thinking and acting
- Teamwork orientation
- Proficiency in German and English (written and spoken)
**Desirable Skills/Experience**:
- First experience in regulatory affairs in a Swiss organization, but we are also offering the opportunity for graduates to join AstraZeneca
- Knowledge of French and/or Italian is advantageous
**Why AstraZeneca?**
When we put unexpected teams in the same room, we ignite bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.
At AstraZeneca, we change the practice of medicine and improve the patient experience by generating and communicating compelling medical evidence. We translate the wealth of medical and scientific expertise to ensure the data we produce helps physicians to better treat patients at every point in the journey. We are recognized as the strategic partner for Research & Development and Commercial, which means we have a deep understanding of both functions. This enables us to effectively translate scientific evidence into clinical practice for patients. We demonstrate our partnerships with external experts across the industry, to build and communicate evidence that changes medical practice.
-
Manager, Regulatory Affairs
vor 7 Stunden
Baar, Zug, Schweiz Biogen VollzeitAbout This RoleAs Manager, Regulatory Affairs , you will lead regional Regulatory Affairs (RA) activities for biosimilars beyond centralized authorizations, coordinating with Affiliate RA to identify and fulfill national regulatory requirements to support successful product launches. You will oversee product updates across multiple countries and manage key...
-
Manager, Regulatory Affairs
vor 6 Stunden
Baar, Zug, Schweiz Biogen VollzeitAbout This RoleAs Manager, Regulatory Affairs, you will lead regional Regulatory Affairs (RA) activities for biosimilars beyond centralized authorizations, coordinating with Affiliate RA to identify and fulfill national regulatory requirements to support successful product launches. You will oversee product updates across multiple countries and manage key...
-
Principal, Commercial Regulatory Affairs
vor 6 Stunden
Baar, Zug, Schweiz Novocure VollzeitJOB SUMMARY:The Principal Regulatory Affairs Specialist is part of the Novocure Global Regulatory Affairs (RA) team. In this role, you will be a critical interface between regulatory strategy and commercial execution, ensuring that launch readiness, indication expansion initiatives, promotional and advertising materials for our medical device products comply...
-
Regulatory Affairs Manager
Vor 5 Tagen
Baar, Schweiz Universal-Job VollzeitIn this role you are responsible for leading regional regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialisation. Your accountabilities will include: - Responsible for defining Biosimilar regulatory...
-
Global Corporate Affairs Operation Director
Vor 5 Tagen
Baar, Schweiz Medison Pharma VollzeitMedison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. - As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring...
-
Cmc Mature Products Regulatory Manager
vor 2 Wochen
Baar, Schweiz GSK Vollzeit**Site Name**: USA - Pennsylvania - Upper Providence, Baar Onyx, Belgium-Wavre, GSK HQ, Poznan Grunwaldzka, USA - Massachusetts - Waltham, USA - North Carolina - Durham, Ware **Posted Date**: Oct 16 2025 **Job Purpose**: Responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products. **Key Responsibilities**: -...
-
Medical Affairs Manager
vor 2 Wochen
Baar, Schweiz AstraZeneca Vollzeit**Medical Affairs Manager - Respiratory** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. We are pushing the...
-
CMC Mature Products Regulatory Manager
vor 2 Wochen
Baar, Zug, Schweiz GSK VollzeitSite Name:USA - Pennsylvania - Upper Providence, Baar Onyx, Belgium-Wavre, GSK HQ, Poznan Grunwaldzka, Rockville Biopharm, USA - Massachusetts - Waltham, USA - North Carolina - Durham, WarePosted Date:Oct Job Purpose:Responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products.Key Responsibilities:Responsible for the...
-
Regulatory Project Manager
Vor 7 Tagen
Baar, Schweiz GSK Vollzeit**Site Name**: UK - London - New Oxford Street, Baar Onyx, Belgium-Wavre, Poznan Grunwaldzka **Posted Date**: Jan 14 2025 We are looking for an ambitious Regulatory Project Manager to ensure the development of regulatory strategies and their execution for assigned asset(s) consistent with the strategic activities for GSK’s Classic & Established Product...
-
Associate Director, Global Regulatory Strategy
Vor 2 Tagen
Baar, Schweiz Biogen Vollzeit**About this role** The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy. Responsibility of leading the global and EU regulatory strategy for the development of...