Vaga de Sr Regulatory Specialist, Pharmaceutical Solutions & HPC Support, LATAM
1 vaga: | Publicada em 10/02
- A Combinar
Sobre a vaga
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
Support to existing product portfolio in their pharmaceutical and HPC applications
for new market/applications and introduction of existing products into additional
countries/jurisdictions within the region.
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
Please submit your resume in English - we can only consider applications submitted
in this language.
IFF is an Equal Employment Opportunity Employer
Its 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.
At IFF, we believe that your uniqueness unleashes our potential. We value the
diverse mosaic of the ethnicity, national origin, race, age, sex or veteran
status. We strive for an inclusive workplace that allows each of our colleagues to
bring their authentic self to work regardless of their religion, gender identity &
expression, sexual orientation, or disability. Visit
IFF.com/careers/workplace-diversity-and-inclusion to learn more.