
Analyst Regulatory Affairs
4 semanas atrás
Regulatory Affairs Group
**Job Sub Function**:
Regulatory Affairs
**Job Category**:
Professional
**All Job Posting Locations**:
São Paulo, Brazil
Main Responsibilities:
- Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance.
- Execute activities to obtain or update establishment registration licenses.
- Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.
- Request and follow-up of documentation to prepare registration dossiers.
- Supports regional team on product submissions schedules, prioritization, and pipeline management.
- Support internal and external audits with documentation requests.
- Interacts with other JJ stakeholders, government agencies in a professional, decisive, & articulate manner.
- Act as a point of contact for stakeholders to support business plans and regulatory needs.
- Review labels compliance in internal system.
- Support implementation and regulatory assessment of new regulations.
- Elaborate procedures of the area.
- Organize team meetings and elaborate agenda and minutes.
- Manage quality issues.
- Manage compulsory certification and GMP activities.
Qualifications:
- 1-2 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Brazilian Health Authorities and a successful track record
- Bachelor's Degree in Engineering, Pharmacy or other life science
- Knowledge of Local & International Regulation and Processes
- Analytical capability and investigative skills
- Prioritizes work to meet deadlines, sense of urgency
- Advanced level of English
- Desirable experience in Medical Devices or Pharma background
-
São Paulo, São Paulo, Brasil PTC Therapeutics, Inc. Trabalho remoto Freelance Tempo inteiroContractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role) Join to apply for the Contractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role) role at PTC Therapeutics, Inc. Contractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role) 1 day ago Be among the first 25 applicants Join to apply for the Contractor, Sr. Analyst,...
-
Contractor, Sr. Analyst, Regulatory Affairs
2 semanas atrás
São Paulo, São Paulo, Brasil PTC Therapeutics, Inc. Trabalho remoto Freelance Tempo inteiroContractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role)Join to apply for the Contractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role) role at PTC Therapeutics, Inc.Contractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role)1 day ago Be among the first 25 applicantsJoin to apply for the Contractor, Sr. Analyst, Regulatory...
-
Regulatory Affairs Analyst
Há 2 dias
São Paulo, São Paulo, Brasil Novo Nordisk Tempo inteiro**Regulatory Affairs Analyst (São Paulo/SP)**As a Regulatory Affairs Analyst you will maintain an open and fluent communication flow with different external stakeholders on Affiliate level, preparing routine correspondence with regulatory agencies.Also, you will collaborate with other departments in the affiliate (Marketing, Legal, Logistics, Sales)...
-
Senior Regulatory Affairs Professional
Há 3 dias
São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiroRegulatory Affairs Full AnalystThis is a challenging and rewarding role for an individual who is passionate about ensuring the highest standards of regulatory compliance in our industry.Job Description:The Regulatory Affairs Full Analyst will be responsible for working closely with cross-functional teams to plan, prepare, and execute regulatory processes...
-
Regulatory Affairs Junior Analyst
4 semanas atrás
São Paulo, São Paulo, Brasil Biogen Tempo inteiroCompany DescriptionAt Biogen, our mission is clear: we are pioneers in neuroscience. Since our founding in 1978 as one of the world's first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.Our mission to find therapies for neurological and rare...
-
Regulatory Affairs Specialist
Há 3 dias
São Paulo, São Paulo, Brasil beBeeRegulatoryAffairs Tempo inteiro R$900.000 - R$1.200.000Regulatory Affairs ProfessionalThis role seeks a detail-oriented individual with excellent communication skills, capable of navigating complex regulatory environments. You will collaborate with a dynamic team focused on delivering key regulatory insights.Main Responsibilities:Build and maintain relationships between UBS and local regulators to ensure...
-
Regulatory Affairs Expert
Há 8 horas
São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro US$150.000 - US$200.000Regulatory Affairs Expertise in BiopharmaceuticalsWe are seeking a skilled Regulatory Affairs Associate Director to lead our biopharmaceutical regulation process, ensuring seamless compliance with target country legislation and efficient execution.This role will play a pivotal part in supporting our global strategy on regulatory matters, fostering...
-
Analyst Regulatory Affairs
4 semanas atrás
São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiroFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's...
-
Regulatory Affairs Specialist
Há 3 dias
São Paulo, São Paulo, Brasil beBeeregulatory Tempo inteiro R$64.000 - R$97.000Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to support regional Chemistry, Manufacturing and Control (CMC) strategy, the preparation of documentation, and the execution of regional post-approval submissions and new product registrations.Main Responsibilities:Assess regulatory change control by identifying requirements...
-
Key Regulatory Affairs Specialist
Há 2 dias
São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$150.000 - R$200.000Regulatory Affairs Manager RoleWe are seeking a skilled Regulatory Affairs professional to develop and maintain strong client relationships, participate in regulatory processes, prepare documents, and communicate with clients and authorities.Responsibilities:Develop and maintain long-term client partnerships.Participate in the development of regulatory...