Manager Regulatory Affairs

Vor 4 Tagen

Zurich, Schweiz Experis Vollzeit

**Manager Regulatory Affairs**

Experis IT is on the search for a **Manager Regulatory Affairs** to join one of their clients, a well-known international pharma company based in Switzerland.

**Contact**:Francesca De Chirico

**Start Date: ASAP**

**Duration**:12** **M**onths**

**Location**:Zürich**

**Workload percentage**:100%**

**Hybrid Model**

**Key Responsibilities**:

- Ensures regional regulatory strategies are written, reviewed and executed according to plan.
- In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
- Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle.
- Partners with the regional market access and colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making.
- May be called upon to provide direction to senior leadership, as relevant.
- Develops and maintains effective working relationships with EUCAN RA and Marketed Product Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners as required.
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility.
- In collaborate on with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.
- Authors and oversees execution for more complex regional regulatory strategies as needed.
- Under supervision from a senior team member and/or Line Manager, sometimes leads and manages meetings and / or interactions with regulatory authorities and agency meetings; in alignment with line manager can negotiate on behalf of project team as necessary.
- Under supervision from a senior team member and/or Line Manager, sometimes represents the company in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps.
- Pro-actively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support company strategic goals and objectives
- Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or higher governance bodies in these areas
- Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management
- Presents regional regulatory strategies to senior management as applicable

**Your Skills**:

- A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 6 years regulatory and/or related experience.
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
- Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU.
- Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy.
- Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region (as relevant to role) with global involvement also preferred.
- Able to understand broad concepts within regulatory affairs and implications across the organization and globally.
- Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Experience managing relationships with CROs and/or contractors also preferred.

**Physical Demands**:

- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.

Don't hesitate and send us your CV and testimonials today through the link in the advert.

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact **Francesca De Chirico **on **+41 (0) 44 2299925**.

Even though this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland.

Linkedin: Francesca De Chirico

  • Regulatory Affairs Manager

    Vor 3 Tagen

    Zurich, Schweiz NonStop Consulting Vollzeit

    Regulatory Affairs Manager role - Switzerland (German) - CMC I am currently looking for an experienced Regulatory affairs manager, CMC to join a good reputation employer in a German canton of Switzerland. In your role you will be responsible for all CMC aspects, providing strategic and operational guidance to different teams in order to ensure achieving the...

  • Regulatory Affairs Manager

    vor 7 Monaten

    Zurich, Schweiz Sonova Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Regulatory Affairs Manager

    vor 2 Stunden

    Zurich, Schweiz Advanced Bionics Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Zurich, Schweiz Pfizer Vollzeit

    **Regulatory Affairs Manager (M/F)** **Contract limited** **This is what you can look forward to**: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. -...

  • Regulatory Affairs Coordinator

    Vor 5 Tagen

    Zurich, Schweiz Pfizer Vollzeit

    Weltweit arbeiten die Mitarbeiter von Pfizer gemeinsam daran, die Gesundheit eines jeden Einzelnen überall zu verbessern. Während wir Arzneimittel und Medizin-Produkte entwickeln und unser Geschäft global ausweiten, halten wir jederzeit Ausschau nach neuen Talenten. Derzeit suchen wir Sie an unserem **Standort in Zürich **als: Regulatory Affairs...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Zurich, Schweiz LHH Vollzeit

    Für unseren Mandanten mit Niederlassung im Grossraum Zürich suchen wir einen **Regulatory Affairs Manager (m/w/d)**. Ein familiärer Umgang und eine täglich gelebte Wertschätzung zeichnen das Unternehmen aus. Aufgabengebiet - Mitarbeit in Projektteams und Schnittstelle zu anderen Fachabteilungen hinsichtlich der regulatorischen Anforderungen bei der...

  • Regulatory Affairs Manager

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...

  • Regulatory Affairs Cmc Manager

    Vor 3 Tagen

    Zurich, Schweiz CSL Behring Vollzeit

    CSL Vifor is a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company. We are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. - Effectively collaborate with technical experts, oversee and direct compilation and update of CMC related dossier components,...

  • Regulatory Affairs Coordinator

    vor 1 Woche

    Zurich, Schweiz Pfizer Vollzeit

    Weltweit arbeiten die Mitarbeiter von Pfizer gemeinsam daran, die Gesundheit eines jeden Einzelnen überall zu verbessern. Während wir Arzneimittel und Medizin-Produkte entwickeln und unser Geschäft global ausweiten, halten wir jederzeit Ausschau nach neuen Talenten. Derzeit suchen wir Sie an unserem Standort in Zürich als: Regulatory Affairs Coordinator...

  • Global Regulatory Affairs Labelling Manager

    vor 7 Monaten

    Zurich, Schweiz CSL Behring Vollzeit

    CSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham,...

  • Eucan Regulatory Affairs Manager, Oncology

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **EUCAN Regulatory Affairs Manager, Oncology,** based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Provides regional strategic and tactical advice and guidance to teams to...

  • Head Regulatory Affairs Emerging Markets

    vor 7 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic and visionary leader with a strong background in regulatory affairs within the...

  • Director Regulatory Affairs

    vor 7 Monaten

    Zurich, Schweiz Sonova Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Director, Global Regulatory Affairs Cmc

    Vor 6 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Join Takeda as a Director, Global Regulatory Affairs (GRA) CMC, where you will lead GRA CMC Due Diligence in partnership with organizational and external stakeholders. You will ensure the communication/development of regulatory CMC risks and strategy, develop best practices that enable CMC due diligence, ensuring that a given compound meets technical and...

  • Regulatory Affairs Manager Pharma Eu/ch

    vor 7 Monaten

    Zurich, Schweiz Bernwald Personalberatung Vollzeit

    Unsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat. - In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d). **IHRE AUFGABEN**: - Selbständiges Erstellen von CMC-Zulassungsdokumentationen - Termingerechte...

  • Project Manager Global Affairs

    vor 7 Monaten

    Zurich, Schweiz Global Affairs Vollzeit

    Global Affairs_ **Project Manager Global Affairs (m/w/d)** **80 % **:Die Abteilung Global Affairs der Universität Zürich (UZH) fördert und pflegt die weltweite Zusammenarbeit der Universität mit Partnerhochschulen und Institutionen in der internationalen (bildungs-)politischen Landschaft und im akademischen Umfeld mit dem Ziel, die internationale...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zurich, Schweiz Akina Vollzeit

    Akina is a leading developer of medical software to empower patients during independent physiotherapy at home. With an AI-driven motion coach and unique entertainment integration, Akina addresses the lack of clinical feedback and motivation that causes 4 out of 5 patients to fail during self-care at home today. As a regulatory affairs manager at Akina, you...

  • Head of Regulatory Affairs

    vor 2 Wochen

    Zurich, Schweiz Global Kader Personal Vollzeit

    **INTRODUCTION**: - For our client, a Swiss pioneer in ESG data science located in Zurich, we are looking for an individual as **Head of Regulatory Affairs**: - (Full time, unlimited contract) The earliest start date is as soon as possible. **ASSIGNMENT DESCRIPTION**: - Define a regulatory affairs strategy and articulate a business plan, including...

  • Junior Regulatory Affairs Manager

    vor 7 Monaten

    Zurich, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Junior Regulatory Affairs Manager

    vor 7 Monaten

    Zurich, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...