Senior Representative, Regulatory Affairs
Company: Disability Solutions
Location: Bloomington
Posted on: April 25, 2024
Job Description:
We're hiring for a Senior Regulatory Affairs Specialist to
support compliance and regulatory affairs in Bloomington,
Indiana!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 Senior Regulatory Affairs
Specialist serves as the liaison to clients and internal functional
departments for all matters regulatory and compliance related. The
regulatory affairs department is accountable for the direct
management and guidance regarding these matters for our biologics,
cGMP facility. The team works with clients and internal
cross-functional departments to provide guidance and support
services through a product's life cycle. This is a full-time,
salaried position and is 100% site based. The schedule is Monday -
Friday 1st shift. --Catalent Biologics in Bloomington, Indiana--is
a state-of-the-art,--GMP manufacturing facility,--providing one
million--sq/ft of drug substance manufacturing, drug product
manufacturing, and related pharmaceutical services. This
award-winning facility helps customers accelerate biologic drug
development programs and bring better treatments to help patients
live better, healthier lives.-----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
- Review new and update facility drug master files.
- 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.
- Provide written documentation of interactions with regulatory
agencies.
- Assist in the maintenance of facility registrations.
- Develop and implement regulatory strategies to facilitate
registrations and client relationships.
- Serve as a regulatory resource for clients.
- Other duties as assigned.The Candidate
- Bachelor's Degree required.
- Master's Degree preferred.
- RAPS Certificate preferred.
- 5-8 of related experience within pharmaceutical
manufacturing.
- 6 years of GMP experience preferred.
- Must be able to read and understand English-written job
instructions and safety requirements.Why you should join Catalent:
- Defined career path and annual performance review and feedback
process.
- Medical, dental and vision benefits effective on first day of
employment.
- Potential for career growth on an expanding team and
organization.
- 152 hours of paid time off annually plus 8 paid holidays.
- Community engagement and green initiatives.
- Competitive salary with bonus potential.
- Tuition reimbursement program.
- Diverse, inclusive culture.
- Generous 401K match.---Catalent 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.--Catalent is
committed to the health and safety of its employees, visitors and
the customers and patients we serve. As a result of the global
pandemic, we have modified many of our recruitment and on-boarding
processes to maintain everyone's safety. The Human Resources teams
will communicate all necessary safety processes and procedures
throughout each stage.------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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