Regulatory Affairs Manager
3 semanas atrás
The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide Regulatory Consulting for ODS Applications, New Marketing Authorisation Applications, as well as Swiss variation and PSUR submissions.
Key Responsibilities/Scope of the Job
Manage client's product portfolio
Prepare the Swiss submissions based on applications submitted in EU or elsewhere including all documents
needed for inclusion in module 1 of the eCTD. Perform a quality check on the documentation for suitability for submission to Swissmedic (validation according to Swissmedic requirements).
Create/update the Swiss Product Information (Information for Professionals and Patient Information as applicable) based on the SmPC approved in the EU or elsewhere.
Prepare module 1 documents (forms, locally required documents etc.) based on the documentation provided by Company (e.g., module 1 from the EU submission). Indicate sufficient hyperlinking for Swissmedic purposes.
Perform/Support submissions activities to Swissmedic through the appropriate electronic gateway and support client during the entire regulatory process.
Establish and maintain contact with the national regulatory authorities (Swissmedic) on behalf of client
Assist client's in national regulatory affairs issues and provide advice on national-specific requirements related to clients product(s)
Monitor national Regulatory Affairs legislation and continuously inform client of new or changed national requirements that affect client's products
Advise client on current Swissmedic requirements for packaging materials.
Co-ordinate end to end local activities including artwork and proof reading
aRMM submissions, adaptation, and maintenance (translation)
Update product information to relevant local HA databases
Position Qualifications
Education/Learning Experience/Work Experience
A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance)
Experience of regulatory requirements in countries outside the US and Europe
Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset
Experience from leading projects and cross-functional teams
German language on B2/C1 level
Personal Attributes
A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds
Highly self-motivated and able to drive activities
Excellent communication skills
The suitable candidate should demonstrate the values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership
Ensure exemplary behavior, ethics and transparency within the Company and with regulatory agencies
#LI-Remote
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Lisbon, Portugal Elanco Tempo inteiroAt Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose –...
-
Senior Associate Regulatory Affairs
Há 1 mês
Lisbon, Portugal Amgen Tempo inteiroHOW MIGHT YOU DEFY IMAGINATION? THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP ) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross-functional capabilities, including Commercial, General and Administrative, Information Systems, Research and Development, and more. The ACCP will offer rich career...
-
Public Affairs Manager
Há 1 mês
Lisbon, Portugal Novo Nordisk AS Tempo inteiroAre you a seasoned expert in driving Public Affairs strategies and initiatives, with a demonstrated passion for catalysing meaningful policy change? Are you enthusiastic about navigating complex issues and diverse stakeholder landscapes? Are you ready to embrace and conquer challenges as an integral part of your daily work, utilizing your exceptional...
-
Public Affairs Manager
3 semanas atrás
Lisbon, Portugal Novo Nordisk AS Tempo inteiroAre you a seasoned expert in driving Public Affairs strategies and initiatives, with a demonstrated passion for catalysing meaningful policy change? Are you enthusiastic about navigating complex issues and diverse stakeholder landscapes? Are you ready to embrace and conquer challenges as an integral part of your daily work, utilizing your exceptional...
-
Lisbon, Portugal Amgen Tempo inteiroHOW MIGHT YOU DEFY IMAGINATION? The Amgen Capability Center in Lisbon, Portugal (ACCP) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross functional capabilities, including Commercial, General and Administrative, Research and Development and more. The ACCP will offer rich career growth and...
-
Public Affairs Manager
4 semanas atrás
Lisbon, Portugal Novo Nordisk Tempo inteiroAre you a seasoned expert in driving Public Affairs strategies and initiatives, with a demonstrated passion for catalysing meaningful policy change? Are you enthusiastic about navigating complex issues and diverse stakeholder landscapes? Are you ready to embrace and conquer challenges as an integral part of your daily work, utilizing your exceptional...
-
Public Affairs Manager
3 semanas atrás
Lisbon, Portugal Novo Nordisk Tempo inteiroAre you a seasoned expert in driving Public Affairs strategies and initiatives, with a demonstrated passion for catalysing meaningful policy change? Are you enthusiastic about navigating complex issues and diverse stakeholder landscapes? Are you ready to embrace and conquer challenges as an integral part of your daily work, utilizing your exceptional...
-
Regulatory Compliance Project Manager
3 semanas atrás
Lisbon, Portugal SGS Tempo inteiroJob Description We are looking for an experienced Regulatory Compliance product manager to join SGS DIGICOMPLY in Chiasso and lead our clients onboardings, Regulatory and food safety project implementations and renewals. This role is fundamental in ensuring that customers are getting the most out of the SGS Digicomply platform. You'll play a key role to...
-
Regulatory Compliance Project Manager
2 meses atrás
Lisbon, Portugal SGS Tempo inteiroJob Description We are looking for an experienced Regulatory Compliance product manager to join SGS DIGICOMPLY in Chiasso and lead our clients onboardings, Regulatory and food safety project implementations and renewals. This role is fundamental in ensuring that customers are getting the most out of the SGS Digicomply platform. You'll play a key role to...
-
Lisbon, Portugal IQVIA Tempo inteiroPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Lisbon, Portugal IQVIA Tempo inteiroPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Government Affairs Advisor, Spain and Portugal
2 semanas atrás
Lisbon, Portugal Lightsource BP Tempo inteiroSummary In a new role in the Government Affairs team, you will be supporting the development of the government affairs function in Portugal and Spain to realize Lightsource bp as a local leader within the sector and advance our company goals and ambitions. Working in close partnership with the Senior Manager for Government Affairs for Southern...
-
Associate Manager, Clinical Trials Regulatory Management
2 meses atrás
Lisbon, Portugal IQVIA Tempo inteiroPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...
-
Associate Manager, Clinical Trials Regulatory Management
3 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...
-
Brand Manager Professional Health Care
4 semanas atrás
Lisbon, Portugal HARTMANN Tempo inteiroNa HARTMANN dedicamo-nos a ajudar , cuidar , proteger e crescer . Apoiamos os profissionais de saúde, para que estes possam concentrar-se no que realmente importa: impactar positivamente a vida das pessoas. Criamos soluções que fazem a diferença e com o teu compromisso poderás desenvolver-te...
-
Brand Manager Professional Health Care
2 meses atrás
Lisbon, Portugal HARTMANN Tempo inteiroNa HARTMANN nos dedicamos a ajudar , cuidar , proteger e crecer . Apoiamos os profissionais de saúde para que estes possam se concentrar no que realmente importa: impactar positivamente a vida das pessoas. Criamos soluções que fazem a diferença, e com o vosso comprometimento, você poderá se...
-
Brand Manager Professional Health Care
3 semanas atrás
Lisbon, Portugal HARTMANN Tempo inteiroNa HARTMANN dedicamo-nos a ajudar , cuidar , proteger e crescer . Apoiamos os profissionais de saúde, para que estes possam concentrar-se no que realmente importa: impactar positivamente a vida das pessoas. Criamos soluções que fazem a diferença e com o teu compromisso poderás desenvolver-te...
-
Regulatory Business Analyst – DORA Implementation
2 meses atrás
Lisbon, Portugal Taleo Consulting Tempo inteiroMission. Our banking client is on the lookout for an experienced Regulatory Business Analyst to join our dynamic team. This role will play a crucial part in the implementation of the Digital Operational Resilience Act (DORA) , covering all six pillars of the program. What will you do? Act as a Business Analyst supporting the 6 pillars within...
-
Regulatory Business Analyst – DORA Implementation
3 semanas atrás
Lisbon, Portugal Taleo Consulting Tempo inteiroMission. Our banking client is on the lookout for an experienced Regulatory Business Analyst to join our dynamic team. This role will play a crucial part in the implementation of the Digital Operational Resilience Act (DORA) , covering all six pillars of the program. What will you do? Act as a Business Analyst supporting the 6 pillars within...
-
Advisor-R&D
4 semanas atrás
Lisbon, Portugal Elanco Tempo inteiroAt Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose –...