Senior Regulatory Affairs Associate

2 semanas atrás

BrazilRemote, Brasil Parexel Tempo inteiro

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include preparing and reviewing CMC packages, supporting GMP submissions, managing change control assessments, and ensuring compliance with regulatory requirements across multiple regions. The role requires strong technical regulatory expertise, excellent writing skills, and the ability to evaluate scientific CMC information for accuracy. A degree in biological or health sciences (Regulatory Affairs preferred) and at least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry are essential.

Activities:

  • Author global CMC variation submissions (m1/2/3), including responses to HA requests.

  • Author CMC components for annual reports and renewals (m1/2/3), including responses to HA requests.

  • Author CMC components for global MAA (m1/2/3) rollouts (post 1st wave approvals), including responses to HA requests.

  • Author CMC components for tender applications (m1/2/3).

  • Support CMC GMP submissions, e.g., site registrations.

  • Change control assessments (Client to assess major impact countries, vendor to assess impact for all other countries).

  • Confirm CMC requirements for submission e.g. variation, renewal, tender, etc.

  • Align with the client (information flow to be defined) on technical information to be provided and timelines.

  • Preparation of the CMC packages.

  • Provide packages for internal client review and update these as needed.

  • Provide finalized packages for publishing and QC published output.

  • Update of internal systems (RIMS, Publishing, eDMS) or documentation as needed.

  • Support requests for information from HAs or from affiliates/partners.

  • Complete change control assessments for non-major impact countries.

Education:

  • University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD).

  • Degree in Regulatory Affairs is advantageous, but not mandatory.

Experience:

  • Minimum of 5 years' experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC.

  • Sound knowledge in natural sciences with a focus on biological/vaccines/small molecule medicinal products.

  • Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia).

  • Strong regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.

  • Knowledge in Good Manufacturing Practice or related areas would be highly regarded.

  • Senior Regulatory Affairs Associate

    2 semanas atrás

    Brazil-Remote Parexel Tempo inteiro

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Senior Regulatory Affairs Consultant

    1 semana atrás

    Brazil-Remote Parexel Tempo inteiro

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Senior Regulatory Affairs Associate

    Há 4 dias

    Brazil-Remote Parexel Tempo inteiro

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Regulatory Officer

    4 semanas atrás

    Brazil NonStop Consulting Tempo inteiro

    Regulatory Officer - Agrochemical Sector (International Scope) Location: Netherlands (Relocation Support & Visa Sponsorship Provided) Are you an experienced regulatory professional with a passion for plant science, compliance, and international markets? A global player in the agrochemical and crop protection sector , headquartered in the Netherlands , is...

  • Senior Product Manager in Brazil

    2 semanas atrás

    Brazil (Remote) dLocal Tempo inteiro

    Why should you join dLocal? dLocal enables the biggest companies in the world to collect payments in 40 countries in emerging markets. Global brands rely on us to increase conversion rates and simplify payment expansion effortlessly. As both a payments processor and a merchant of record where we operate, we make it possible for our merchants to make inroads...

  • Associate Technical Customer Support

    2 semanas atrás

    Remote, Brazil Fortive Tempo inteiro

    Description LocationMust be Based in Brazil - Remote positionWhy You Should Join Intelex?At Intelex, we empower organizations to improve Environmental, Health, Safety, and Quality performance through innovative software solutions. As part of our Support Team, you'll play a critical role in helping customers succeed by ensuring they get the most out of our...

  • Analista De Assuntos Regulatórios

    2 semanas atrás

    São Paulo, State of São Paulo, Brazil PharmEng Technology Tempo inteiro

    , permanentPosition: Analista de Assuntos RegulatóriosPharmEng Technology is a leading pharmaceutical consulting firm specializing in regulatory affairs, quality assurance, and compliance. We are currently seeking a highly motivated and experienced Analista de Assuntos Regulatórios to join our team in São Paulo, Brazil.As an Analista de Assuntos...

  • Senior Associate

    2 semanas atrás

    São Paulo, State of São Paulo, Brazil SmartHire Tempo inteiro

    Position Title: Senior Associate ImpactLocation: Remote Based anywhere in BrazilAnnual Salary: USD $35,434 / BRL $212,606Benefits:$30 USD monthly allowance for mobile and broadbandSelf-learning allowance related to the roleAbout the Company:We are a mission-driven, fast-growing global organization focused on unlocking economic opportunity through...

  • Contract Clinical Research Associate

    1 dia atrás

    Brazil Barrington James Tempo inteiro

    Senior Clinical Research Associate (CRA) — Epilepsy Study (Phase II/III)I’m currently looking for experienced Senior CRAs to join an exciting Phase II/III Epilepsy Study with one of my key clients. This is a 1.0 FTE contract role supporting 6–8 sites across Brazil — and it’s available for an immediate start.If you’re someone who thrives in...

  • Contract Clinical Research Associate

    Há 2 dias

    Brazil Barrington James Tempo inteiro

    Senior Clinical Research Associate (CRA) — Epilepsy Study (Phase II/III) I’m currently looking for experienced Senior CRAs to join an exciting Phase II/III Epilepsy Study with one of my key clients. This is a 1.0 FTE contract role supporting 6–8 sites across Brazil — and it’s available for an immediate start . If you’re someone who thrives in...