Empleos actuales relacionados con Head of Regulatory Affairs - Santiago de Chile - Sandoz

  • Regulatory Affairs Specialist

    hace 2 días

    Santiago de Chile Novo Nordisk A tiempo completo

    Regulatory Affairs Specialist **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:Santiago, Región Metropolitana, CL **The Position** - You will also: - Identify the best regulatory pathways and timelines for submission. Communicate and assess global strategies while collaborating with business units to define local approaches. - Compiling,...

  • Regulatory Affairs Country Lead

    hace 5 días

    Santiago de Chile Johnson & Johnson A tiempo completo

    Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...

  • Regulatory Affairs Coordinator

    hace 2 semanas

    Santiago de Chile Pfizer A tiempo completo

    **JOB SUMMARY**: - Participate in the planning of Regulatory strategies for products submissions and lifecycle including also the APIs related to products under responsibility - Coordinate and execute activities related to Dossier planning and submission -paper and/or electronic - for initial registration and maintenance of Drug products including product...

  • Regulatory Affairs Specialist

    hace 1 semana

    Santiago, Metropolitana, Chile Select Assistants A tiempo completo

    OverviewThe Select Assistants team is seeking a skilled Regulatory Affairs Specialist to ensure compliance and regulatory excellence within our medical skincare brand. This role requires expertise in skincare regulations, formulation compliance, and product testing.About the RoleWe are looking for a seasoned professional with extensive experience in...

  • Regulatory Affairs Manager

    hace 2 semanas

    Santiago de Chile Artixio Consulting Pvt Ltd A tiempo completo

    **Company Description** ArtiXio is a global consulting and services company specializing in Regulatory Affairs, Market Access, and Pharmacovigilance for pharmaceutical, biotech, cosmetics, medical device, and dietary supplements manufacturers. Our services cover compliance, regulatory intelligence in over 70 countries, regulatory operations, post-market...

  • Regulatory Affairs Analyst

    hace 2 semanas

    Santiago de Chile Novartis A tiempo completo

    387432BR **Regulatory Affairs Analyst**: Chile **About the role** 1.066.824. That’s the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who...

  • Regulatory Affairs Coordinator

    hace 2 días

    Santiago, Metropolitana, Chile Syneos Health, Inc. A tiempo completo

    Regulatory Affairs CoordinatorSyneos Health is a global biopharmaceutical solutions organization committed to accelerating customer success. We strive to put the customer and patient at the center of everything we do.We believe in developing our people through career progression, technical training, and a supportive work environment. Our employees already...

  • Regulatory Affairs Analyst

    hace 6 días

    Santiago de Chile Novo Nordisk A tiempo completo

    Can you drive the global strategy for culture, engagement and performance management at Novo Nordisk? Do you have the interpersonal skills to navigate in a complex stakeholder landscape and are you able to motivate, set direction and deliver results? At Novo Nordisk, we are our people. And together we can make an impact. **The Position** **Main...

  • Regulatory Affairs Analyst

    hace 2 semanas

    Santiago de Chile Novartis A tiempo completo

    1.066.824. That’s the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical...

  • Regulatory Affairs Analyst

    hace 4 días

    Santiago de Chile Pfizer A tiempo completo

    JOB SUMMARY- Support the Regulatory team in the activities associated to new product registration and post approval changes during product lifecycle for the assigned portfolio.- Work in collaboration across the Country to deliver efficiencies in regulatory submissions and processes.- Interact with local Regulatory Teams, Regional Hub Teams, PGS, GCMC, GRO...

  • Regulatory Affairs Specialist, Export Countries

    hace 5 días

    Santiago de Chile Solventum A tiempo completo

    **Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) - Chile or Colombia- 3M Health Care is now Solventum- At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations...

  • Regulatory Affairs and Quality Assurance Manager

    hace 4 semanas

    Santiago, Metropolitana, Chile Select Assistants A tiempo completo

    Are you a compliance-driven professional with expertise in skincare regulations and a passion for innovation? Join a premium medical skincare brand that has been shaping the industry for over 30 years. As aRegulatory Affairs and Quality Assurance Manager , you'll play a critical role in ensuring regulatory excellence, driving product compliance, and...

  • Regulatory Affairs and Quality Assurance Manager

    hace 1 semana

    Santiago, Metropolitana, Chile Select Assistants A tiempo completo

    Are you a compliance-driven professional with expertise in skincare regulations and a passion for innovation? Join a premium medical skincare brand that has been shaping the industry for over 30 years. As aRegulatory Affairs and Quality Assurance Manager , you'll play a critical role in ensuring regulatory excellence, driving product compliance, and...

  • Regulatory Compliance Officer

    hace 2 semanas

    Santiago, Metropolitana, Chile Merck Sharp & Dohme Corp. A tiempo completo

    At Merck Sharp & Dohme Corp., we are seeking a highly skilled Regulatory Compliance Officer to join our regulatory affairs team. As a key member of our global regulatory affairs group, you will be responsible for ensuring compliance with regulatory requirements and ensuring the accuracy and completeness of regulatory submissions.The ideal candidate will...

  • Senior Reg Affairs Specialist

    hace 2 semanas

    Santiago de Chile Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Regulatory Affairs Specialist

    hace 1 semana

    Santiago, Metropolitana, Chile Bitfinex A tiempo completo

    Founded in 2012, Bitfinex is a digital asset trading platform offering state-of-the-art services for digital currency traders and global liquidity providers. We're on a mission to create the most innovative cryptocurrencies exchange. This is a unique opportunity, a rare window of time at the tipping point of financial evolution. Much like the early days of...

  • Medical Affairs Director

    hace 2 semanas

    Santiago, Metropolitana, Chile Tevapharm A tiempo completo

    Tevapharm is a leading manufacturer of generic medicines, committed to making good health more affordable and accessible. We're on a mission to help millions around the world enjoy healthier lives.Our WorkAs a key member of our Medical Affairs team, you'll play a crucial role in supporting the development and commercialization of our products. Your primary...

  • Regulatory Affairs Director

    hace 5 días

    Santiago, Metropolitana, Chile Amicorp Group A tiempo completo

    Compliance Function LeaderWe are seeking an experienced Compliance professional to lead our Compliance function in the local office. The role holder will be accountable for implementing and maintaining Amicorp's Compliance framework, ensuring adherence to regulatory requirements and identifying areas for improvement.The key responsibilities...

  • Head of Legal Affairs for Chile and Ecuador

    hace 5 días

    Santiago, Metropolitana, Chile Sandoz International GmbH A tiempo completo

    In this role as a Head of Legal Affairs for Chile and Ecuador, you will play a critical part in shaping the future of Sandoz International GmbH. We are seeking a seasoned legal professional with at least 8 years of experience in the pharmaceutical industry, with expertise in contractual negotiations and statutory obligations.You will be responsible for...

  • Senior Regulatory Affairs Specialist Latam

    hace 2 semanas

    Santiago, Metropolitana, Chile Bitfinex A tiempo completo

    Founded in 2012, Bitfinex is a digital asset trading platform offering state-of-the-art services for digital currency traders and global liquidity providers.We're on a mission to create the most innovative cryptocurrencies exchange.This is a unique opportunity, a rare window of time at the tipping point of financial evolution.Much like the early days of the...

Head of Regulatory Affairs

hace 2 semanas

Santiago de Chile Sandoz A tiempo completo

**Major Activities**

Team and culture
- Leads, develops and manages the RA department
- Selects, recruits and retains high calibre staff
- Sets objectives, reviews progress, manages and coaches direct line reports

Compliance:

- Ensures Regulatory Compliance and Governance
- Defines overall standards required for regulatory submissions and ensures adherence to Sandoz standards, and local health authority legislation and expectations.
- Oversees implementation of the relevant (local) procedures, and record management.
- Evaluates impact and anticipate future trends, implications of important emerging guidelines and changes in political environment, which are likely to affect Sandoz’ interest.
- Represent RA during internal and external audits and health authority inspections at country level.

**Activities to support Sandoz and our customers**
- Leads the RA department strategy in country and aligns with Regional and Global regulatory strategy (where relevant)
- Accountable for creation & translation of official product information including Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks)
- Accountable for timely implementation of changes of the registered text into artworks
- Provides regulatory support (general and product-specific) to the internal organization (e.g. Business Units and Portfolio & Launch, Medical)
- Leads, develops and maintains good relations with Sandoz Global Regulatory and other Sandoz RA country organizations
- Leads working interface with key internal and external stakeholders. Represent Sandoz at trade organizations and at health authorities regarding (changes in) regulatory affairs legislation.
- Leads, manages and undertakes regulatory across the Medical/Marketing/Market Access/QA/PS interface
- Plays an active role in the local launch team to achieve the company’s business objectives
- Acts as Sponsor and Contributor to relevant local and global business initiatives to ensure DRA is seen as a “Best in Class” organization. Drive process optimization for operational excellence and set priorities for the team.
- Ensures Regulatory Compliance for all registered products, in close cooperation with the QA department
- Ensures that all relevant Key Performance Indicators (including Safety label Changes, Artwork, Checklists, Deviations, RA input in RMP implementation and DHPC communication, are achieved timely & correctly

**General Sandoz requirements**
- Adhere to Sandoz values and behaviours policies
- Adhere to Sandoz's anti-bribery, confidentiality, and ethical standards and policies.
- Adhere to relevant GxP and pharmacovigilance requirements as established in the processes and tools.

**Country specific additional activities**

Robust and efficient management of distribution partners to ensure timely registration and launch of new products, and regulatory compliance of marketed products.

null
null