Regulatory Affairs Associate

hace 6 días


Lima, Perú GSK A tiempo completo

In GSK Consumer Healthcare, we are on an incredible journey as we prepare to create a new, standalone, world leading company with a 100% single-minded focus on everyday health. We are doing this at a time when the work we do has never mattered more. With the COVID pandemic, people are increasingly looking for ways to manage their own health and wellbeing and to take care of their families. This is where we come in. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we are uniquely placed to deliver better everyday health to millions of people around the world and grow a strong, successful business. This is an opportunity to be part of something special.”

This position is Multilocation

As a, we empower you to be yourself, share ideas and work collaboratively.

**_
Your Responsibilities:_**

This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

Proactively manage impact of regulatory changes within defined scope of responsibility on the business.
- Analyze regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs. Look for opportunities with regional supportive team to reduce submission/ approval timelines. At the same time complying with our internal policies and local regulations
- Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance.
- Correct handling and timely updating of regulatory systems such as Veeva Regulatory, local databases, and other systems with regulatory information with high impact to the business such as SAP.
- Give support to other deparments: Permanent interaction as regulatory reference for Sales, Marketing, Customer Supply Chain, Medical, Demand and Legal to assure the business continuity and for any activity where regulatory support is required
- To review and approve promotional materials of products under his/her responsibility so that these materials are in accordance with health regulations.
- To participate in labelling process reviewing and approving the artworks of the products under his/her responsibilities, providing the input from the regulatory perspective and assuring the artworks are in accordance with health regulations
- To interact with Health Authorities, local registrations contact and regulatory associations. If required

**_
Why you?
- **

**Basic Qualifications**:
We are looking for professionals with these characteristics to achieve our goals:

- Pharmaceutical degree is required.
- English and Spanish level: advanced.
- 3+ years of experience in similar roles with demonstrated success in managing health registrations processes for Central American and Caribbean and desirable in other Latam countries meeting high standards of quality
- In
- depth knowledge of the current health regulatory framework for drug regulatory procedures.

**_
Inclusion & Diversity at CH:_**
**Inclusion and diversity at GSK are key for our success.** Here, you will thrive through bringing your **unique experiences** to both our company and the recruitment process. We want you to **be you, feel good and keep growing your career.**
**GSK is an Equal Opportunity and Affirmative Action Employer.** Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. **Beyond this, we commit to our values of integrity and respect towards every applicant.**
**We want to hear from you and support with** **any adjustments that you may require during the recruitment process.** Please get in touch with our Recruitment Team to further discuss this today.
- Important notice to Employment businesses/ Agencies_



  • Lima, Perú Medtronic A tiempo completo

    **Careers that Change Lives **In this exciting role as an Associate Regulatory Affairs Specialist, you will be in charge to prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned by Senior...


  • Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...


  • Lima, Perú Thermo Fisher Scientific A tiempo completo

    We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and...


  • Lima, Perú Johnson & Johnson Family of Companies A tiempo completo

    **Regulatory affairs specialist**: At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of groundbreaking and innovation, which has been impacting the health of more than 1 billion...


  • Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client...


  • Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description**: The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance,...

  • Regulatory Affairs Intern

    hace 3 semanas


    Lima, Perú Boston Scientific Corporation A tiempo completo

    **Work mode**: **Onsite Location(s)**:Lima, LIM, PE **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 of the most...


  • Lima, Perú Johnson & Johnson A tiempo completo

    **REGULATORY AFFAIRS PROJECT MANAGEMENT SPECIALIST**: At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1...


  • Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client...


  • Lima, Perú Johnson & Johnson A tiempo completo

    Prepares regular and ad hoc integrated data mining and analyses for sales management to facilitate identifying potential marketing opportunities based on analysis and interpretation of internal and external factors that affect sales performance, providing insights to sales and marketing management on sales force effectiveness. At Johnson & Johnson, the...


  • Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office We are currently seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team...


  • Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completo

    The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical...


  • Lima, Perú Tether Operations Limited A tiempo completo

    Tether Operations LimitedPEN 70,000 - 100,000 (estimated)Company Overview: Tether is a pioneering company in the stablecoin and blockchain industry, committed to pushing the boundaries of innovation and technology.About the Role: We are seeking an experienced Regulatory Affairs Strategist to design and execute global regulatory strategies for our biotech...


  • Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completo

    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring...


  • Lima, Perú Johnson & Johnson A tiempo completo

    En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad._ - La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y...

  • Sr Reg Affairs Spec

    hace 2 meses


    Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects. You will be part of a global team providing innovative...


  • lima, Perú Thermo Fisher Scientific A tiempo completo

    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that...


  • Lima, Perú Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid **Onsite Location(s)**:Lima, LIM, PE **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 of the...

  • Reg Affairs Manager

    hace 2 meses


    Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client...


  • Lima, Perú Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client...