Sr Regulatory Specialist, Pharmaceutical Solutions

2 semanas atrás

Barueri, Brasil International Flavors & Fragrances Tempo inteiro

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.

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