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Regulatory affairs specialist Jobs in Adliswil

Zuletzt aktualisiert: vor 13 Stunden
Regulatory Affairs Manager

Regulatory Affairs Manager

ExperisZurich
Experis is the global leader in professional resourcing and project-based workforce solutions.On behalf of our Pharmaceutical company in Zurich we are looking for a Manager Regulatory Affairs with ...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
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Managing Director

Managing Director

Morgan Philips Group SAZürich, Zürich, Switzerland
Regulatory & Clinical Affairs Specialist.Experts in developing devices for minimally invasive surgery and imaging, my client in their growth phase has partnered with me to find the right fit! We ar...Mehr anzeigenZuletzt aktualisiert: vor 13 Stunden
Head Medical & Regulatory Affairs(Mitglied der GL)

Head Medical & Regulatory Affairs(Mitglied der GL)

WILHELMZürich
Fachverantwortung in tollem Familienunternehmen.Falk Pharma AG, ist ein international tätiges, familiengeführtes Pharmaunternehmen mit einer langen Tradition in der Entwicklung und Vermarktung inno...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Verantwortliche •r Public Affairs

Verantwortliche •r Public Affairs

Energie 360° AGZürich, CH
Das Team Regulatory & Transformation treibt die Transformation von fossilen zu erneuerbaren Energien in der Stadt Zürich und in Städten & Gemeinden in der Schweiz im Sinne der jeweiligen Energiepol...Mehr anzeigenZuletzt aktualisiert: vor 27 Tagen
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Responsable - Conseil en Technologie - Cybersécurité

Responsable - Conseil en Technologie - Cybersécurité

EYZürich, Zürich, Switzerland
Director, Europe & Canada (EUCAN) Communications.Competitive salary and benefits.Here at AstraZeneca, you’ll be valued for your unique knowledge. It means we are trusted with personal accountability...Mehr anzeigenZuletzt aktualisiert: vor 19 Stunden
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Medical Science Liaison Manager Cardiovascular Disease (80-100 %)

Medical Science Liaison Manager Cardiovascular Disease (80-100 %)

Daiichi SankyoZürich, Zürich, Switzerland
Select how often (in days) to receive an alert : .Medical Science Liaison Manager Cardiovascular Disease (80-100 %).With over 120 years of experience and more than 17,000 employees in over 20 countri...Mehr anzeigenZuletzt aktualisiert: vor 19 Stunden
Talent pool - Switzerland

Talent pool - Switzerland

Ascendis PharmaZürich, ZH, CH
Quick Apply
Denmark, Germany, the United States, UK, Italy, Spain, and France, and we are still growing.We are applying our TransCon® technology to build a leading, fully integrated biopharmaceutical company f...Mehr anzeigenZuletzt aktualisiert: vor 17 Tagen
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Head Regulatory & Medical Affairs 80 – 100 %

Head Regulatory & Medical Affairs 80 – 100 %

TN SwitzerlandZürich, Zürich, Switzerland
Head Regulatory & Medical Affairs 80 – 100 %, Zürich.Sie übernehmen die Abteilungsleitung zur regulatorischen Betreuung der Human- und Veterinär-Präparate. Führung, Coaching und Weiterentwicklung de...Mehr anzeigenZuletzt aktualisiert: vor 19 Stunden
Ass. Director, GRA Regional TA Lead

Ass. Director, GRA Regional TA Lead

CSLEMEA, CH, Kanton Zurich, Opfikon, CSL Vifor
Vollzeit
We are looking for an experienced and experienced TA Lead / Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contributing to ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Head Regulatory (m|f|x)

Head Regulatory (m|f|x)

E FundresearchZürich, Zürich, Switzerland
The Head Regulatory is responsible for tracking new regulations, coordinating the implementation of new regulations, and managing interactions with regulators. The Head Regulatory also manages an in...Mehr anzeigenZuletzt aktualisiert: vor 19 Stunden
Manager Medical Affairs (m / f / d) Diabetes Care Austria and Switzerland

Manager Medical Affairs (m / f / d) Diabetes Care Austria and Switzerland

AbbottBaar, Zug, Switzerland
Abbott Diabetes Care is a global leader in diabetes management, committed to helping people with diabetes lead healthier, happier lives. Through continuous innovation and a steadfast commitment to q...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
Associate Director, Device and Drug-Device Combinations Strategic Sourcing Operations

Associate Director, Device and Drug-Device Combinations Strategic Sourcing Operations

TakedaZurich, Switzerland
Vollzeit
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and ot...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Head Regulatory & Medical Affairs 80 – 100 %

Head Regulatory & Medical Affairs 80 – 100 %

Stettler Consulting AGStandort Grossraum Zürich
Sie übernehmen die Abteilungsleitung zur regulatorischen Betreuung der Human- und Veterinär-Präparate.Führung, Coaching und Weiterentwicklung des Regulatory- und Medical-Teams.Aufteilung der Verant...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Sales für Startup : B2B SaaS, f / m / •, 60-100%

Sales für Startup : B2B SaaS, f / m / •, 60-100%

PolitAnalytics AGZürich, Zurich, Switzerland
Homeoffice
Quick Apply
Wir sind eine Monitoring- und Knowledge-Management-Lösung im Bereich "Public Affairs" bzw.Als SaaS Sales und Business Developer •in spielst du eine entscheidende Rolle bei der Akquisition von Geschä...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Regulatory Business Analyst

Senior Regulatory Business Analyst

iO AssociatesZurich
Regulatory Business Analyst : 9 month contract opportunity : .April - 31st December (9 months).We are seeking several dynamic and detail-oriented Regulatory Business Analysts to join a team commencing...Mehr anzeigenZuletzt aktualisiert: vor 19 Tagen
Regulatory Affairs Manager

Regulatory Affairs Manager

ProclinicalZürich, Schweiz
Proclinical is seeking a Regulatory Affairs Manager to lead the team, focusing on Marketed Products Development in Growth and Emerging Markets. This role involves developing strategies to ensure reg...Mehr anzeigenZuletzt aktualisiert: vor 3 Tagen
Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

Regulatory Affairs Manager for Austria and Switzerland (Alpine region)

Alexion PharmaceuticalsSwitzerland,Baar
Vollzeit
Regulatory Affairs Manager for Austria and Switzerland (Alpine region).Reports to : Associate Director, CENE Regulatory Affairs. The Regulatory Affairs Manager works under the responsibility of the A...Mehr anzeigenZuletzt aktualisiert: vor 20 Tagen
Regulatory Banking Specialist Senior Associate / Manager

Regulatory Banking Specialist Senior Associate / Manager

PwCZürich
Vollzeit
SummaryA career within General Consulting services, will provide you with the opportunity to help clients seize essential advantages by working alongside business leaders to solve their toughest pr...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Quality Affairs Specialist D / e 50%, Mit Option Zu 100%

Quality Affairs Specialist D / e 50%, Mit Option Zu 100%

Five Office LtdAgglomeration Zürich / Oberland, CH
Ihre pharmazeutisch-technische Ausbildung und Erfahrung im Qualitätsbereich mit einer systematischen und exakten Arbeitsweise. Sie erfüllen Ihre Aufgaben bei einem Partner von Five Office Ltd in des...Mehr anzeigenZuletzt aktualisiert: vor 26 Tagen
Regulatory & Compliance Legal Counsel – Healthcare / Pharmaceutical / Med Tech (Zurich or remote in Switzerland)

Regulatory & Compliance Legal Counsel – Healthcare / Pharmaceutical / Med Tech (Zurich or remote in Switzerland)

AxiomZurich, Switzerland
Homeoffice
Advise on regulatory and compliance matters within the healthcare and pharmaceutical sectors.Develop and implement compliance programs. Ensure adherence to pharmacovigilance and medical affairs regu...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Regulatory Affairs Manager

Regulatory Affairs Manager

ExperisZurich
Vor 2 Tagen
Stellenbeschreibung

Experis is the global leader in professional resourcing and project-based workforce solutions.

On behalf of our Pharmaceutical company in Zurich we are looking for a Manager Regulatory Affairs with experience in Marketed Products Development, Growth and Emerging Markets (GEM)

General Information :

Start date : Asap

Duration : 6 months

Loction : Zurich (hybrid working is possible)

Language requirement : English

Competencies and Skills :

  • Bachelor's degree in a scientific discipline; BA accepted based on experience. Advance degree preferred.
  • Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and / or post-marketing phases
  • 4 years of directly related regulatory experience is desirable
  • Solid regulatory experience, including knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets; and US and EU (relevant to role), including interaction with Health Authorities
  • Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and / or development strategies
  • Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
  • Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
  • Generally strong and independent skills in regulatory strategy such as understanding broad concepts within regultory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
  • Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
  • Effective manager who is able to bring working teams together for common objectives

Accountabilities :

  • Collaborates to define, develop and lead Marketed Products GEM strategies to maximize regulatory success towards achievement of program objectives
  • Independently manages, plans and executes all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program
  • Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs
  • Stays current with regulations / guidances in Growth and Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance
  • Provides regulatory expertise on Marketed Products in GEM for multiple projects, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance and life cycle management
  • Assures ongoing efforts towards fulfilment of international product approval conditions for late stage programs
  • Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company's consultants and Business Partners
  • Evaluates new business development opportunities for Growth and Emerging Markets and / or participates on due diligence teams
  • In coordination with local regulatory lead provides strategic guidance / advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs
  • Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents GEM RA in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required
  • Manages, trains, provides direction, strategic guidance and solutions to projects, mentors team members, to support scope of project work
  • Partner with the regional / LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans
  • If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23