Sr Regulatory Specialist, Pharmaceutical Solutions
Há 3 dias
The Sr Regulatory Specialist is responsible for providing hands-on regulatory support for the development and maintenance of our Pharmaceutical Solutions and HPC business within the region. This role includes involvement in the relevant Pharmaceutical Solutions and HPC product and substance registrations and direct agency interaction within the region. This role will provide regulatory support to regional customers directly and can be engaged in regional industry associations as appropriate.
**Job Requirements**:
- Active involvement with new projects and new product developments and supporting dossier work on an as needed basis.
- Proper involvement in relevant risk evaluation and management processes.
- Involvement with local competent authorities and trade associations on an as needed basis.
- Support of regional, and as needed global, regulatory issues to the different internal stakeholders (e.g. commercial teams, quality, operations,) as well as external stakeholders (e.g., customers).
- Interfaces with internal business functions to support business plans, development opportunities and R&D objectives.
- Involvement with customer regulatory filings as needed in alignment with IFF policies
- Develop, submit and support regional dossiers as needed.
- Provide regional regulatory input during cross functional business projects.
- Support regulatory customer requests
**External Focus**:
- Can be expected to spend 10% of the time traveling to support regional business-customer interactions, trade associations or interacting with government officials.
**Preferred Experience and Qualifications**:
- Knowledge of the global and regional regulatory landscape for pharmaceutical excipients and their use in finished drug products
- Knowledge of the global and regional regulatory landscape for HPC products and their use
- Global and/or regional experience in interaction with regulatory agencies and track record in product clearance/registrations and regulatory advocacy
- Subject matter expertise on EU and US pharmaceutical regulations, excipients will be an added advantage
- MSc or BSc degree in Pharmaceutical Science, Regulatory Science, Biology, Toxicology, or Chemistry or similar fields
- + 5 years Regulatory Affairs work experience
- Fluent English
- Demonstrate analytical, conceptual and strategic thinking as well as excellent communication skills across a global team
- Strong interpersonal skills
- Very good organization, and project management competencies Strong influencer and collaborator with interdisciplinary teams**IFF is an Equal Employment Opportunity Employer**:
It’s an exciting time to be part of the IFF family. We are a global leader in taste, scent and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy.
-
Sr Regulatory Specialist, Support for Hpc and
2 semanas atrás
Barueri, Brasil International Flavors & Fragrances Tempo inteiroIn the Global Regulatory Affairs (GRA) team we have an opening for a **Sr Regulatory Specialist for the LATAM** region to drive regulatory activities for our Home & Personal Care (HPC) and H&B/Health business segments. The Global Regulatory Affairs organization employs more than 300 highly specialized and committed colleagues worldwide and has a footprint in...
-
Global Regulatory Affairs Animal Nutrition and Health Specialist
3 semanas atrás
Barueri, Brasil IFF Tempo inteiroOverview The Global Regulatory Affairs Animal Nutrition and Health Specialist will manage regulatory work for the Health and Biosciences Animal Nutrition and Health (AN&H) business, with a focus on animal feed applications for Latin America. This position is responsible for regulatory document development and compilation for registration/market access as...
-
Sr. Applications Scientist
Há 7 dias
Barueri, Brasil International Flavors & Fragrances Tempo inteiroJob Description IFF Pharma Solutions is one of four (4) divisions of the company, focused on developing the most essential pharmaceutical, dietary supplement, and industrial polymer solutions. Our leading excipient brands are found in one (1) out of every three (3) tablets in the world; we have a broad plant-based portfolio for a variety of supplement...
-
Sr. Account Manager
3 semanas atrás
Barueri, Brasil Motorola Solutions Tempo inteiroCompany Overview At Motorola Solutions, we believe that everything starts with our people. We’re a global close-knit community, united by the relentless pursuit to help keep people safer everywhere. Our critical communications, video security and command center technologies support public safety agencies and enterprises alike, enabling the coordination...
-
Sr Technical Perfumer
1 semana atrás
Barueri, São Paulo, Brasil IFF Tempo inteiro R$80.000 - R$120.000 por anoJob SummaryAt this stage, the SR Technical Perfumer demonstrates good leadership skills. Manage and build good relationship with internal and external customers. Completing Organizational Leadership Program is a mandatory requirement.Responsible for the coordination of regional formula modifications and provides coaching and mentorship to JR Technical...
-
Sr. Specialist Accounting
3 semanas atrás
Barueri, Brasil adidas Tempo inteiroOverview Join to apply for the Sr. Specialist Accounting role at adidas Direct message the job poster from adidas Purpose & Overall Relevance for the Organization Secures financial operations by monitoring and approving financial processing, reporting; ensure that accounting records and documentation comply with the requirements of the Group Finance Manual....
-
gerente medico diabetes
2 semanas atrás
Barueri, São Paulo, Brasil The businesses of Merck KGaA, Darmstadt, Germany Tempo inteiro R$90.000 - R$120.000 por anoYour Role In the operations role, you will act as a therapeutic/product specialist for local medical affairs. You will co-lead the brand or local launch team in developing therapeutic strategies, launches, and branding.You will lead medical affairs activities in the designated territory, in accordance with defined local medical launch strategies.You will...
-
Sr. Digital Advertising Specialist, Latin America
2 semanas atrás
Barueri, Brasil Ingersoll-Rand Plc Tempo inteiroSenior Digital Advertising Specialist, Latin America and CaribbeanLocation: Brazil, Colombia, Chile and MexicoAbout UsIngersoll Rand is a global market leader with a broad range of innovative and mission-critical air, fluid, energy, and medical technologies, providing services and solutions to increase industrial productivity and efficiency.We think and act...
-
Sr. Digital Advertising Specialist, Latin America
2 semanas atrás
Barueri, Brasil Ingersoll Rand Tempo inteiroIngersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition,...
-
Sr. Digital Advertising Specialist, Latin America
2 semanas atrás
Barueri, Brasil Ingersoll Rand Compressor Systems & Services Tempo inteiro1 day ago Be among the first 25 applicants Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic...