Senior Global Regulatory Affairs - CMC Scientist Consultant
Company: Eurofins Scientific Services
Location: Indianapolis
Posted on: May 27, 2023
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Job Description:
Company Description
Eurofins Scientific is an international life sciences company,
providing a unique range of analytical testing services to clients
across multiple industries, to make life and our environment safer,
healthier and more sustainable. From the food you eat, to the water
you drink, to the medicines you rely on, Eurofins laboratories work
with the biggest companies in the world to ensure the products they
supply are safe, their ingredients are authentic and labelling is
accurate.
The Eurofins network of companies is the global leader in food,
environment, pharmaceutical and cosmetic product testing and in
agroscience Contract Research Organisation services. It is one of
the market leaders in certain testing and laboratory services for
genomics, discovery pharmacology, forensics, advanced material
sciences and in the support of clinical studies, as well as having
an emerging global presence in Contract Development and
Manufacturing Organisations. It also has a rapidly developing
presence in highly specialised and molecular clinical diagnostic
testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes,
France to 58,000 staff across a decentralised and entrepreneurial
network of 900 laboratories in over 54 countries. Eurofins
companies offer a portfolio of over 200,000 analytical methods to
evaluate the safety, identity, composition, authenticity, origin,
traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and
has been among the best performing stocks in Europe over the past
20 years.
Job Description
Position Overview:
This position will provide strategic, tactical and operational
direction and support to expedite CMC development of our client's
clinical trial portfolio by developing successful regulatory
strategies and submissions in support of clinical trials.
In order to meet client expectations, it is necessary for our
entire PSS team to develop collegial and mutually productive
relationships with CMC team members.
This position utilizes CMC technical knowledge and regulatory
expertise to drive internal consistency and influence effective
change management. This team will be expected to influence and
execute regulatory strategies that can accelerate the development
of assigned project(s).
Job Responsibilities:
Qualifications
The Ideal Candidate would possess:
Minimum Qualifications:
Additional Information
Position is full-time with overtime as needed. Candidates currently
living within a commutable distance of Indianapolis, INare
encouraged to apply.
What we offer:
Eurofins Lancaster Laboratories Professional Scientific Services -
(PSS) is a global, award-winning insourcing solution that places
our people at our clients' site dedicated to running and managing
laboratory services while eliminating headcount, co-employment and
project-management worries.
We infuse our 55-year track record of scientific and laboratory
operations expertise, as well as HR and great place to work best
practices, to recruit, hire, train and manage highly qualified
scientists to perform laboratory services using our client's
quality systems and equipment.
To learn more about Eurofins Lancaster Laboratories, please explore
our websitewww.eurofinsus.com .
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Eurofins is a M/F, Disabled, and Veteran Equal Employment
Opportunity and Affirmative Action employer.
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Keywords: Eurofins Scientific Services, Indianapolis , Senior Global Regulatory Affairs - CMC Scientist Consultant, Professions , Indianapolis, Indiana
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