Regulatory Affairs Analyst

hace 1 semana


Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

**Regulatory Affairs Analyst**:

- Remote Eligible: Hybrid- Onsite Location(s): Buenos Aires, B, AR**Additional Locations**: Argentina-Buenos Aires

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

**Purpose Statement**

Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registration and new regulations from government body.

**Job Scope and Leveling Guidelines**

Knowledge

Problem Solving

Applies professional concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems. Follows standard practices and procedures in analyzing situations or data from which answers can be obtained.

Planning and Organization

Plans, organizes, and prioritizes own daily work routine to meet established schedule with guidance from manager.

Discretion/Latitude; Supervision Received; Decision Making

Receives general supervision. Makes recommendations which may be reviewed by manager. May exercise authority within limits. May seek guidance in resolving problems.

Business Relationships and Project Management

Begins establishing and cultivating internal business relationships to facilitate completion of tasks. May participate in project teams.

Impact

Participates in the completion of departmental projects and goals. Errors in judgment or failure to achieve results would normally require an expenditure of resources to rectify.

Liaison

Engages with internal company and occasional external contacts. Uses discretion, diplomacy and tact in interactions.

**Key Responsibilities**
- Provides input on regulatory-related issues associated with compliance and achieving the business plan.
- Prioritize and plan on product registration for his/her respective product lines.
- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. Provide the management team with regular updates on product registration.
- Ensure product registrations are reviewed and renewed as required.
- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
- Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
- Supports tender operations by timely supply of accurate regulatory documents.
- Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
- Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
- Serves as regulatory consultant to marketing team and government regulatory agencies.

**What are we looking for in you?**
- Product registration for Argentina
- Uruguay distributor management
- Execute registrations
- Change of maintenance, products.
- Registration process, ANMAT, customs, mkt.
- Regulatory work together with mkt.
- English. Be able to read, write and speak.
- INTERMEDIATE-ADVANCED EXCEL.
- KPI INDICATORS MANAGEMENT
- Studies in Pharmacy, Bioengineering, Biochemistry

**Requisition ID**:547824

**Job Segment**:Regulatory Affairs, Compliance, Medical Device, Project Manager, Legal, Healthcare, Technology, Entry Level



  • Buenos Aires, Argentina Novo Nordisk A tiempo completo

    **Regulatory Affairs Specialist** Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key business challenges? Then we might have the right position for you. We are looking for a Regulatory Affairs Analyst...


  • Buenos Aires, Buenos Aires C.F., Argentina Bioceres Crop Solutions A tiempo completo

    At Bioceres Crop Solutions, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring the successful development and commercialization of our biotechnology products.The primary responsibilities of this position include:Developing and...


  • Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completo

    Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases. Medison is rapidly growing in the international markets backed...


  • Buenos Aires, Buenos Aires C.F., Argentina Viseven A tiempo completo

    Viseven is seeking a highly experienced Global Regulatory Affairs Manager to lead our Regulatory Affairs team. As a key member of the IRO, you will be responsible for developing and implementing global regulatory strategies, ensuring compliance with relevant laws, standards, and regulations.Key responsibilities include:Team OperationsDevelop and maintain IRO...


  • Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid **Onsite Location(s)**:Buenos Aires, C, AR **Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    Introduction/Purpose 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...

  • Regulatory Affairs

    hace 7 días


    Buenos Aires, Argentina Parexel A tiempo completo

    A Regulatory Affairs Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. A Project Leader must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and...


  • Buenos Aires, Argentina Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Corega, Centrum, Alikal, Uvasal, Hinds - through a unique combination of deep human understanding...


  • Buenos Aires, Buenos Aires C.F., Argentina IQVIA Argentina A tiempo completo

    The Senior Regulatory Affairs Manager is responsible for ensuring compliance with all applicable local and international regulations. This includes performing feasibility, site ID, start up and site activation activities in accordance with SOPs and work instructions.Essential Functions:Serve as SPOC for assigned studies, ensuring adherence to SOPs, quality...


  • Buenos Aires, Argentina UPL ltd A tiempo completo

    **Regulatory Affairs Coordinator**: - Job Id: 4555- City: Buenos Aires, Buenos Aires, Argentina- Department: REGISTRATIONS- Function: Regulatory, Research and Development- Employee Type: Permanent Full Time- Seniority Level: Not Applicable- Description: - **Somos UPL, somos OpenAg y nos comprometemos a seguir construyendo una red agrícola que alimente el...


  • Buenos Aires, Buenos Aires C.F., Argentina Glencore International AG A tiempo completo

    Glencore International AG is a leading global commodity trading and mining company seeking an experienced Regulatory Affairs Specialist to join our team in Buenos Aires, Argentina.Our Purpose is to responsibly source the commodities that advance everyday life. The products we source and market play an essential role in modern life. From the copper, cobalt,...


  • Buenos Aires, Buenos Aires C.F., Argentina Bioceres Crop Solutions A tiempo completo

    We are looking for a Regulatory Affairs Manager to join our Bioceres Crop Solutions teamThe mission of the position is to give support and execute Bioceres regulatory strategy for biotechnological traits and products on target crops, in order to obtain and maintain regulatory approvals in all relevant locations in a timely manner.Be the primary interface of...


  • Buenos Aires, Argentina Amgen A tiempo completo

    Career Category Regulatory **Job Description**: Sr. Associate Regulatory Affairs Ensure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase...


  • Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

    Role OverviewThe Regulatory Affairs Associate will be responsible for ensuring compliance with all project-related processes and activities, monitoring and maintaining quality standards and productivity/delivery standards per project requirements, mentoring new team members if assigned by the Manager, and performing medical review of non-serious adverse...


  • Buenos Aires, Argentina Organon A tiempo completo

    Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our...


  • Buenos Aires, Argentina Amgen A tiempo completo

    Sr. Associate Regulatory Affairs Ensure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase when specific strategies or activities that impact a...


  • Buenos Aires, Argentina Coca-Cola A tiempo completo

    Are you an expert in scientific and regulatory affairs with a strong advocacy mindset and robust experience within the food industry? We're looking for a proactive professional who is not only abreast of the constantly evolving regulatory landscape but is also adept at identifying potential risks and opportunities. If this sounds like you, this role could...


  • Buenos Aires, Buenos Aires C.F., Argentina 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...