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Regulatory affair manager

Approach People RecruitmentLausanne, Switzerland

As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, ...Mehr anzeigen

IT Project Manager 100%

T&N Telekom & Netzwerk AGBussigny-près-Lausanne, CH

T&N, ce sont des solutions TIC taillées sur mesure pour les environnements business.Gérée par son propriétaire, T&N a été créée en 1996 et emploie aujourd’hui 180 personnes sur douze sites en Suiss...Mehr anzeigen

Senior Event Concept Designer & Creative Writer

LHHlausanne

Our client is an international recognizable company.The Company is looking for a Senior Event Concept Designer & Copywriter with 5+ years of proven experience in conceptualizing and writing for a w...Mehr anzeigen

Project Manager

EvooqLausanne, Vaud, Switzerland

As a Project Manager, you will lead the end-to-end delivery of client implementation projects and ongoing service management across Evooq’s suite of products.You’ll act as the key bridge between ou...Mehr anzeigen

PMO Integration Manager

Michael Page SuisseVevey, Canton de Vaud, CH

For a fast-growing company in Switzerland The role is responsible for ensuring structured programme governance, milestone tracking, synergy monitoring, and cross-functional coordination throughout ...Mehr anzeigen

Key Account Manager

Bechtle Suisse SAMorges, CH

Avec plus de 16 000 employés, nous sommes l'une des entreprises informatiques les plus prospères et les leaders du marché dans notre secteur.L'association de la vente directe de produits informatiq...Mehr anzeigen

IT Change Manager

ItecorLausanne, VD, CH
Quick Apply

Rejoignez notre entreprise internationale de conseil et de services en IT.Chez Itecor, vous êtes au centre de tout ce que nous faisons.Nos communautés de pratique permettent à nos consultants d'exc...Mehr anzeigen

Innovation Insight Manager

NespressoVevey, Suiza

Nespresso HQ for innovation projects across our B2C and B2B product lines, including coffees, machines, accessories, and more.Your role will ensure that impactful innovations are effectively brough...Mehr anzeigen

Sustainability Manager - Pharma

QuantisLausanne, VD, CH
Quick Apply

Build the partnerships shaping a sustainable future.Do you want to work with leading organizations to help them achieve their sustainability ambitions? .Do you want to be part of a team recognized ...Mehr anzeigen

Office manager

TreaTechPréverenges, Switzerland
Quick Apply

TreaTech est une startup suisse spécialisée dans le développement de technologies de traitement des déchets et de valorisation des ressources, visant à réduire l’impact environnemental.Basée à Prév...Mehr anzeigen

Compliance Investigations Manager

NestléVevey, Suiza

Compliance Investigations Manager.In this pivotal role, you’ll ensure all investigations are conducted in alignment with internal policies, regulatory frameworks, and industry best practices.You’ll...Mehr anzeigen

IT & Business Applications Manager

Interiman group - AlbedisLausanne

Nous sommes à la recherche, pour le compte d'une structure, l'un des leaders mondiaux des solutions d'accès, établi dans la région de.IT & Business Applications Manager.Titulaire d'une formation da...Mehr anzeigen

Manager Contentieux

AdeccoLausanne, Vaud, Switzerland

Notre client, une entreprise reconnue dans son secteur d’activité, recherche un(e).Superviser l’équipe contentieux et coordonner les actions de recouvrement amiable et judiciaire.Définir et mettre ...Mehr anzeigen

 • Gesponsert

Software Project Manager

LogitechLausanne, Switzerland

Logitech is the Sweet Spot for people who want their actions to have a positive global impact while having the flexibility to do it in their own way.Logitech is looking for an experienced Software ...Mehr anzeigen

Retail Area Manager

Talented Search TechnologiesLausanne, Switzerland
Quick Apply

Our client is a leading cosmetics company that offers high-quality cosmetic products.They have innovative makeup, face, and body care products, and the range includes safe and effective products of...Mehr anzeigen

IT & Business Applications Manager

AlbedisLausanne, Vaud - Région Lausannoise

Nous sommes à la recherche, pour le compte d'une structure, l'un des leaders mondiaux des solutions d'accès, établi dans la région de.IT & Business Applications Manager.Titulaire d'une formation da...Mehr anzeigen

 • Gesponsert

PMO Integration Manager

Michael PageVevey, CH

The role is responsible for ensuring structured programme governance, milestone tracking, synergy monitoring, and cross-functional coordination throughout the integration lifecycle.The Integration ...Mehr anzeigen

Engineer Manager

Salt Mobile SAPrilly, CH

Are you a people-first engineering leader who thrives at the intersection of technology and teamwork? Do you make things happen — turning a backlog into working software, while growing the engineer...Mehr anzeigen

IT Network Manager

Michael PageLausanne Region, CH

Encadrement d'une équipe technique réseau, avec accompagnement au quotidien et développement des compétences.Organisation et priorisation des activités : répartition des missions, suivi des charges...Mehr anzeigen

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Regulatory affair manager

Regulatory affair manager

Approach People RecruitmentLausanne, Switzerland
Vor 26 Tagen
Stellenbeschreibung

Job Description

: As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements related to the development, approval, and marketing of pharmaceutical, medical device, or other healthcare products. You will work closely with cross-functional teams to navigate the complex regulatory landscape and to ensure that products meet all applicable regulations and standards.

Responsibilities:

  • Develop and implement regulatory strategies for product development, registration, and commercialization.
  • Prepare and submit regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), 510(k), Pre-Market Approval (PMA), or other regulatory filings, as required.
  • Liaise with regulatory agencies, such as the FDA, EMA, or other regulatory authorities, to facilitate the review and approval process for new products or product changes.
  • Provide regulatory guidance and support to cross-functional teams, including R&D, Clinical Affairs, Quality Assurance, and Marketing, to ensure compliance with regulatory requirements throughout the product lifecycle.
  • Monitor and interpret changes in regulations and guidelines and communicate potential impact to relevant stakeholders.
  • Manage regulatory documentation and maintain regulatory compliance records.
  • Participate in regulatory audits and inspections as needed.
  • Represent the company in regulatory interactions and meetings with regulatory agencies.

Qualifications:

  • Bachelor's degree in a scientific or healthcare-related field; advanced degree Master's or PhD) preferred.
  • Minimum of [X] years of experience in regulatory affairs within the pharmaceutical, medical device, or healthcare industry.
  • Strong understanding of regulatory requirements and guidelines, including FDA regulations (21 CFR), ICH guidelines, and other applicable regulations.
  • Experience with regulatory submissions, including INDs, NDAs, 510(k)s, PMAs, or other regulatory filings.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory agencies.
  • Detail-oriented with strong analytical and problem-solving skills.
  • Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
  • Regulatory Affairs Certification (RAC) preferred.