Senior Representative, Regulatory Affairs
Company: Disability Solutions
Location: Bloomington
Posted on: September 28, 2024
Job Description:
Senior Representative, Regulatory Affairs Catalent is a global,
high-growth, public company and a leading partner for the
pharmaceutical industry in the development and manufacturing of new
treatments for patients worldwide. Your talents, ideas, and passion
are essential to our mission: to help people live better, healthier
lives.--The Regulatory Affairs department is accountable for the
direct management and guidance regarding the organization's cGMP
compliance and regulatory affairs for biologics, sterile
injectables, cell and gene therapy, inhalation manufacturing and
analytical services.------Regulatory Affairs will work with clients
and internal cross-functional teams to provide regulatory strategy
and support services for drug and combination products throughout
the product lifecycle.The main responsibility of a Senior
Regulatory Affairs specialist is to serve as a regulatory liaison
to clients and internal functional departments.This position works
days; Monday - Friday Catalent is committed to a Patient First
culture through excellence in quality and compliance, and to the
safety of every patient, consumer and Catalent employee.The
Role
- Prepare accurate and quality documentation for client
regulatory submissions; provide regulatory guidance and support for
development and production activities
- Maintain awareness of changes in global regulatory requirements
for effective regulatory submissions and production
documentation
- Review regulatory and production documents to ensure compliance
with global requirements, agreements, and other regulations
- Serve as regulatory liaison with the applicable Health
Authorities for assigned projects
- Assist in the maintenance of facility registrations
- Develop and implement regulatory strategies to facilitate
registrations and strategies to facilitate client relationships;
serve as a regulatory resource for clients
- Other duties as assignedThe Candidate
- Bachelor's Degree, required; Master's Degree, preferred
- RAPS Certificate, preferred
- 5 - 8 years of relevant experience --
- 6 years' GMP experience, preferred
- Must be able to read and understand English-written job
instructions and safety requirementsWhy You Should Join Catalent--
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
offers rewarding opportunities to further your career!-- Join the
global drug development and delivery leader and help us bring over
7,000 life-saving and life-enhancing products to patients around
the world. Catalent is an exciting and growing international
company where employees work directly with pharma, biopharma and
consumer health companies of all sizes to advance new medicines
from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one
will be used by someone who is counting on us. Join us in making a
difference.--personal initiative. dynamic pace. meaningful
work.Visit to explore career opportunities.Catalent is an Equal
Opportunity Employer, including disability and veterans.If you
require reasonable accommodation for any part of the application or
hiring process due to a disability, you may submit your request by
sending an email, and confirming your request for an accommodation
and include the job number, title and location to . This option is
reserved for individuals who require accommodation due to a
disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will
provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Bloomington , Senior Representative, Regulatory Affairs, Other , Bloomington, Indiana
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