Regulatory Affairs Manager, Zürich District

vor 2 Wochen


Zürich, Schweiz TN Switzerland Vollzeit

Social network you want to login/join with:

Client:

Proclinical

Location:

Not specified

Job Category:

Other

Job Reference:

a4fe81e53d5f

Job Views:

6

Posted:

03.03.2025

Expiry Date:

17.04.2025

Job Description:

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 regulatory success, enabling patient access, and achieving market objectives. The successful candidate will be responsible for managing submissions and approvals, as well as life-cycle management of products.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:
  1. Create strategies for success in Growth and Emerging Markets.
  2. Manage submissions, approvals, and life-cycle management for assigned programs.
  3. Communicate regulatory strategies and timelines effectively.
  4. Stay updated with regulations impacting drug development and registration.
  5. Provide regulatory expertise on non-clinical and clinical aspects.
  6. Ensure compliance with international product approval conditions.
  7. Build relationships with local and global regulatory teams and business partners.
  8. Evaluate new business opportunities and participate in due diligence.
  9. Provide strategic guidance on emerging trends and regulations.
  10. Lead or support meetings with Health Authorities and manage outcomes.
  11. Mentor team members and provide strategic guidance.
  12. Collaborate with market access colleagues to support product development plans.
Key Skills and Requirements:
  1. Bachelor's degree in a scientific discipline; advanced degree preferred.
  2. Experience in regulatory affairs within the pharmaceutical industry.
  3. Knowledge of regulations governing drugs and biologics in growth and emerging markets.
  4. Experience in managing major regulatory filings and contributing to strategies.
  5. Strong communication, negotiation, and timeline management skills.
  6. Ability to work well in global teams and communicate with senior leadership.
  7. Experience managing relationships with external vendors is preferred.
#J-18808-Ljbffr

  • Zürich, Schweiz Randstad Switzerland Vollzeit

    For our client, an international pharmaceutical company, we are looking for a Regulatory Affairs Manager.General Information:Start date: ASAPEnd date: 15.08.2025Workplace: Zurich,Glattpark-OpfikonDepartment: Global Regulatory AffairsWorkload: 100%Remote/Home office: possibleAbout the job:As a Regulatory Affairs Manager, you will define, develop, and lead...


  • Zürich, Schweiz Experis Switzerland Vollzeit

    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:Duration: 6 monthsLocation: Zurich (hybrid working is...


  • Zürich, Schweiz TN Switzerland Vollzeit

    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:Duration: 6 monthsLocation: Zurich (hybrid working is...

  • Head Medical

    vor 2 Wochen


    Zürich, Schweiz TN Switzerland Vollzeit

    Head Medical & Regulatory Affairs (Mitglied der GL), Zürich DistrictZürich District, SwitzerlandFachverantwortung in tollem FamilienunternehmenUnser Kunde, Dr. Falk Pharma AG, ist ein international tätiges, familiengeführtes Pharmaunternehmen mit einer langen Tradition in der Entwicklung und Vermarktung innovativer Arzneimittel. Das Unternehmen...


  • Zürich, Schweiz Proclinical Staffing Vollzeit

    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 regulatory success, enabling patient access, and achieving market objectives. The successful candidate will be responsible for managing submissions and approvals, as...


  • Zürich, Schweiz elemed Vollzeit

    Direct message the job poster from elemedSenior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | QualityRole: Senior Regulatory Affairs SpecialistThe CompanyAre you an expert in regulatory affairs for medical devices? Are you tired of working in large, slow-moving corporations but worried about joining an unstable start-up? Why not...


  • Zürich, Schweiz elemed Vollzeit

    Direct message the job poster from elemedSenior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | Quality Role: Senior Regulatory Affairs Specialist The CompanyAre you an expert in regulatory affairs for medical devices? Are you tired of working in large, slow-moving corporations but worried about joining an unstable start-up? Why...


  • Zürich, Schweiz Real Staffing Vollzeit

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Real StaffingRecruitment Consultant at SThree | Georgia Tech Scheller College of Business AlumniRegulatory Affairs ManagerMarketed Products Development, Growth and Emerging MarketsDefines, develops and leads GEM strategies to maximize regulatory success to...

  • Head Regulatory

    vor 3 Wochen


    Zürich, Schweiz TN Switzerland Vollzeit

    Head Regulatory & Medical Affairs 80 – 100 %, ZürichZürich, SwitzerlandSie übernehmen die Abteilungsleitung zur regulatorischen Betreuung der Human- und Veterinär-Präparate.Ihre Aufgaben :Führung, Coaching und Weiterentwicklung des Regulatory- und Medical-TeamsAufteilung der Verantwortlichkeiten innerhalb der Abteilung RegistrierungErstellung und...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    We're looking for a professional or recent graduate to join our Private Wealth Management (PWM) Compliance team in Zurich. As a Regulatory Affairs Analyst, you'll provide compliance advisory and surveillance to our PWM business.About the RoleYou'll be responsible for working closely with the PWM Swiss, London and European Compliance teams to deliver...


  • Zürich, Schweiz Planet Pharma Vollzeit

    A leading biotech company at the forefront of developing innovative therapies is seeking a Global Head of Regulatory Affairs to lead its regulatory team and drive global regulatory strategies. This company is dedicated to pioneering breakthrough treatments for challenging medical conditions through a unique therapeutic platform.Key Responsibilities:Develop...


  • Zürich, Schweiz TN Switzerland Vollzeit

    Senior Manager, Regulatory Affairs CMC, ZugJob Description:The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional to assume a full-time employment position in Gilead's office in Zug, Switzerland in the capacity of CMC...


  • Zürich, Zürich, Schweiz La Prairie Group AG Vollzeit

    Responsibilities:We are seeking a dedicated Regulatory Affairs Specialist to join our team at the La Prairie Group AG. As a key member of our regulatory affairs team, you will be responsible for ensuring that all products comply with relevant regulations and industry standards.You will work closely with cross-functional teams to review and approve new...


  • Zürich, Zürich, Schweiz Stettler Consulting AG Vollzeit

    Wir suchen eine flexible und belastbare Persönlichkeit als Abteilungsleiter/in für die regulatorische Betreuung von Human- und Veterinärpräparaten. Als Teil unseres Teams haben Sie die Möglichkeit, Ihre Fähigkeiten und Erfahrungen zu nutzen.AufgabenFührung, Coaching und Weiterentwicklung des Regulatory- und Medical-TeamsAufteilung der...


  • Zürich, Zürich, Schweiz TN Switzerland Vollzeit

    TN Switzerland, the global leader in professional resourcing and project-based workforce solutions, is seeking a seasoned Regulatory Affairs Strategist with expertise in Marketed Products Development, Growth and Emerging Markets (GEM).About the Role:We are looking for an experienced candidate to lead our regulatory efforts in GEM, collaborating with...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    At Takeda, we are committed to fostering a culture of excellence and collaboration. As a Clinical Trial Regulatory Lead, you will be responsible for developing operational implementation plans for clinical trial applications (CTAs) in the EUCAN and GEM regions.This role requires strong regulatory experience, including knowledge of CTA regulations and...


  • Zürich, Zürich, Schweiz Real Staffing Vollzeit

    Job DescriptionWe are seeking a highly experienced Regulatory Affairs Professional to join our team. As a key member of our regulatory team, you will be responsible for leading the development and implementation of global market access strategies for our clients.Key Responsibilities:Develop and execute comprehensive market access plans to ensure timely...


  • Zürich, Schweiz RM IT Professional Resources AG Vollzeit

    **Regulatory Affairs Manager - Marketed Products Development, GEM** vacancy (requiring profound Pharma knowledge) for our Glattpark (Opfikon) based client in the Pharma sector**.** **Your tasks**: - Collaborates to define, develop and lead Marketed Products GEM strategies to maximize regulatory success towards achievement of program objectives -...


  • Zürich, ZH, Schweiz Takeda Pharmaceutical Vollzeit

    The Regulatory Affairs-Labeling, Associate Director is responsible for ensuring that Takeda gains regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of bringing better health to people...


  • Zürich, Schweiz TN Switzerland Vollzeit

    Quality & Regulatory Affairs Manager (100 %), DübendorfDübendorf, SwitzerlandWir sind ein erfolgreiches Schweizer Familienunternehmen in Dübendorf (ZH), welches Arzneimittel, Medizinprodukte und Nahrungsergänzungsmittel in der Schweiz vertreibt. Unsere flexible Struktur, unser ausgeprägtes Qualitätsverständnis und die hohe Fachkompetenz in allen...