Regulatory Affairs Manager
3 meses atrás
- Survey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.
- Responsible for the review, analysis and filing of new records before the regulatory entity in each country.
- Responsible for renewals and monitoring of health records.
- Responsible for responding to the requests or requirements of the territorial entities or legal entities that have any need for information, complaint or disagreement with the products and manufacturing processes.
- Responsible for updating regulatory legislation for the countries in charge at the level: technical, regulatory, quality, pharmacovigilance and marketing.
- Guarantee those responsible for handling medicines the application of good manufacturing practices (GMP)
- Coordination of brands, dossiers and patents within the company
- Take charge of product quality issues in the company's internal and external processes ex : complaints, Discussion with ANVISA, etc
- Manage internal and external processes such as: trades, paperwork, stock depletions for the areas of regulatory affairs and quality.
- Guarantee the updating of the BPM, BPL systems regarding: sanitary records, technical sheets, safety sheets and commercial information.
- Manage communication and coordination with the manufacturer for certificate procedures.
- Comply with the documentation and information provided by the Head Office in India vs. the related information of each health registry in the countries in charge.
- Responsible for the review of packaging and its materials to ensure compliance with regulations in each territory.
- Coordination with the quality area of the logistics operator of the packaging for additional coding processes, packaging changes, inclusion of inserts.
- Co ordinating with responsible PV person to be align with regulatory requirement
- Delegating work to the regulatory affairs team for smooth operations with respect to submissions and life cycle management of the drug product.
- Knowledge and functional skills to exercise the position:
- Experience of 5 to 10 years in the industry of pharmaceutical products for human use.
- Pharmaceutical chemist professional.
- Knowledge of regulatory affairs and quality requirements per regulatory requirement.
- Requirement for dossier submissions for different dosage forms like tablets, Injections and oral solutions. Have complete update knowledge on the RDC's and application of the same.
-
Regulatory Affairs Manager
1 semana atrás
São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiroRegulatory Affairs Job DescriptionAt MSN Laboratories, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our pharmaceutical products.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Affairs Manager
2 semanas atrás
São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiroKey Responsibilities: Survey and implement processes, policies, and procedures to ensure Regulatory Affairs compliance and continuity in each country. Review, analyze, and file new records with regulatory entities in each country. Oversee renewals and monitoring of health records. Respond to requests or requirements from territorial entities or legal...
-
Regulatory Affairs Manager
4 meses atrás
São Paulo, Brasil JM Huber Corporation Tempo inteiroSummary The Regulatory Affairs Manager supports the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (HAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. The RA Manager provides expertise for regulatory affairs projects supporting business maintenance and / or growth and right to...
-
Regulatory Affairs Manager
4 semanas atrás
São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiroRegulatory Affairs Manager Job DescriptionJohnson & Johnson is seeking an experienced Regulatory Affairs Manager to join our team at J&J Innovative Medicine. As a key member of our regulatory affairs team, you will be responsible for overseeing the regulatory activities related to new product introduction, line extension, and new indication, including...
-
Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Gilead Sciences, Inc. Tempo inteiroRegulatory Affairs ManagerGilead Sciences, Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs group, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our cell therapy products.Key Responsibilities:Develop and implement regulatory strategies to...
-
Regulatory Affairs Manager
2 semanas atrás
São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiroJob DescriptionAt MSN Laboratories, we are seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our products.Key Responsibilities:Survey and implementation of processes, policies and procedures that guarantee...
-
Vaga De Regulatory Affairs Team Manager
Há 2 dias
São Paulo, Brasil Catho Online Ltda. - BR - Chefe Tempo inteiroJob title:Regulatory Affairs Team Manager - Vaga Exclusiva Para Pessoas com Deficiencia (PcD)Location:São Paulo/SPAbout the jobRegulatory Affairs team in Brazil is part of a single digitally savvy and agile regulatory community effectively partnering with our diverse business units and platforms by building constructive relationships with Health Authorities...
-
Regulatory Affairs Manager
5 meses atrás
Sao Paulo, Brasil Unilever Tempo inteiro**Unilever is currently hiring for a Regulatory Affairs Manager based in São Paulo.** **Unilever** is the place where you can bring your purpose to life with the work that you do - creating a better business and a better world. We are looking for talents that would like to join this exciting journey with us. Our **R&D Brazil Beauty & Wellbeing** team is...
-
Regulatory Affairs Specialist
2 meses atrás
São Paulo, São Paulo, Brasil JM Huber Corporation Tempo inteiroJob SummaryThe Regulatory Affairs Manager will support the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (HAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. This role will provide expertise for regulatory affairs projects supporting business maintenance and/or growth and right to...
-
Regulatory Affairs Specialist
Há 1 mês
São Paulo, São Paulo, Brasil JM Huber Corporation Tempo inteiroJob SummaryThe Regulatory Affairs Manager supports the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (HAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. This role provides expertise for regulatory affairs projects supporting business maintenance and/or growth and right to operate...
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Gilead Sciences Tempo inteiroRegulatory Affairs Manager - Cell TherapyGilead Sciences is seeking a highly motivated and experienced Regulatory Affairs Manager to join our team in Sao Paulo. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the development and execution of robust regulatory strategies while maintaining regulatory compliance.Key...
-
Regulatory Affairs Manager
2 meses atrás
São Paulo, São Paulo, Brasil JM Huber Corporation Tempo inteiroJob SummaryThe Regulatory Affairs Manager supports the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (SAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. The RA Manager provides expertise for regulatory affairs projects supporting business maintenance and/or growth and right to operate...
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Gilead Sciences, Inc. Tempo inteiroJob Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Sao Paulo, Brazil.About the Role:This is an exciting opportunity for an experienced regulatory professional to lead our Regulatory Affairs team in Brazil, working closely with local, regional, and global teams to...
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Gilead Sciences, Inc. Tempo inteiroRegulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Sao Paulo, Brazil. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maximize regulatory success.Key Responsibilities:Support the definition and...
-
Regulatory Affairs Manager
1 semana atrás
São Paulo, São Paulo, Brasil Intrials Clinical Research Tempo inteiroJob Title: Regulatory Affairs At Intrials Clinical Research, we are seeking a highly skilled and experienced Regulatory Affairs professional to join our team.Primary Responsibilities:Manage the Regulatory & Study Start-up team in all aspects, with support from the Regulatory and Study Start-up Manager (RSM).Support RSM in defining metrics and KPIs for the...
-
Regulatory Affairs Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Kenvue Tempo inteiroRegulatory Affairs Role OverviewKenvue is a leading company in the industry, and we are currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring that our products comply with all relevant regulations and guidelines.Key Responsibilities* Work closely with...
-
Regulatory Affairs Specialist
1 semana atrás
São Paulo, São Paulo, Brasil Gilead Sciences Tempo inteiroJob Title: Regulatory Affairs ManagerGilead Sciences is seeking a highly skilled Regulatory Affairs Manager to join our team in Sao Paulo. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maximize regulatory success.Key Responsibilities:Support the...
-
Regulatory Affairs Manager LATAM
Há 1 mês
São Paulo, São Paulo, Brasil Cardinal Health Tempo inteiroJob Title: Sr. QRA Manager, LATAMThe Regulatory Affairs Manager LATAM plays a critical role in ensuring the organization's compliance with regulatory requirements across the LATAM region. This position is responsible for directing regulatory affairs activities, maintaining relationships with regulatory authorities, and providing insights to senior leadership...
-
Regulatory Affairs Manager
4 semanas atrás
São Paulo, São Paulo, Brasil Danone Tempo inteiroAbout the JobWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Danone. As a key member of our organization, you will play a critical role in ensuring the compliance of our products with regulatory requirements.Key Responsibilities:Identify and mitigate risks to ensure the efficient production of high-quality products.Develop and...
-
Regulatory Affairs Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Quality Compliance Tempo inteiroQuality Compliance is a leading company in the Life Sciences sector, dedicated to excellence in regulatory affairs. We are seeking a talented Regulatory Affairs Manager to join our team and contribute to the company's success.Position Mission:As a Regulatory Affairs Manager, you will be responsible for ensuring compliance with ANVISA and international...