Regulatory Affairs Associate Iii
Company: Amneal Pharmaceuticals
Location: Hoboken
Posted on: July 30, 2022
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Job Description:
Job SummaryThe Regulatory Affairs Associate III, independently
prepares, reviews without appreciable direction and submits high
quality, regulatory submissions such as ANDAs to the FDA within
company timelines and in accordance with regulatory guidelines and
applicable federal laws.Essential FunctionsCompile and complete
high quality ANDAs and Amendments ensuring final submission meet
requirements of ANDA checklist recommended by USFSDA to avoid any
acceptance to file issues. Ensure all submissions and projects are
completed with the expected timeline. Maintains full awareness of
all regulatory activities on assigned projects and ensures that
project deadlines and performance standards for these projects are
established and met. Provides guidance and direction to junior
employeesCoordinates with external vendors for project support
activities. This may include but not limited to: RS statements,
TSE/BSE statements, Melamine free certificates, cGMP certificates,
Debarment certificates, US agent letters, DMF LoAs, Technical data
sheets and technical drawings, Quantitative compositions of colors,
flavors etc., Follow up with purchase team for DMFs and compliance
to DMF review comments.Organize and maintain submission components
associated with a regulatory submission electronically. This may
include scanning, converting to pdf, bookmarking, hyper linking,
electronic processing and uploading in e-CTD Xpress etc.
independently.Reviews ANDAs against Refuse-to-Receive (RTR)
Standards Guidance to prevent deficiencies that could result in
RTR's from the FDA review includes a critical detailed assessment
that technical documentation and information is available, accurate
and complete for submission. Provides guidance and direction to
junior employees for screening of ANDA's against the
checklist.Represents regulatory affairs in project team meetings
and provides regulatory guidance and perspective to team members in
determining appropriate actions in order to meet scheduling
timelines and/or in resolving technical issues. Prepare and update
the road map for each assigned product with committed timeliness by
each department.Evaluate change controls and formulates strategies
for correct filing categories, with guidance from manager.
Proactively raises major project issues if any to manager for
resolution and agreement.Review the API DMFs thoroughly and share
the review comments to purchase department on-time. Follow up with
purchase team or with DMF holder directly as needed to ensure
compliance to provided comments on-time.Additional
ResponsibilitiesWorks with colleagues in resolving regulatory
issues and/or problemsShould archive and maintain all submissions
in a systematic way.Performs administrative functions as directed
by Management to support projects and to ensure the smooth
operation of the department.EducationBachelors Degree (BA/BS) in
Science or Technical RequiredMaster Degree (MS/MA) in Science or
Technical PreferredWork Experience4 years or more Regulatory
submission related work RequiredSkills and AbilitiesDisplay
excellent organization and time management skills, excellent
attention to detail, and ability to multi-task in a high-volume
environment with shifting priorities. AdvancedTime management,
organization and planning skills, multi-tasking and prioritization
skills in a fast-paced environment are required. AdvancedAbility to
maintain a high level of accuracy and attention to detail, while
meeting deadlines for assigned projects. AdvancedExcellent written
and verbal communication skills and interpersonal skills.
AdvancedAbility to communicate effectively and collaboratively as
part of a team in a respectful manner. IntermediateAbility to work
independently, self-starter. AdvancedGood problem-solving skills
and analytical ability. AdvancedAbility to work with professionals
domestically and abroad AdvancedSpecialized KnowledgeStrong skills
in MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat
Professional, ISIWriter, ISIToolBox and eCTDXpress
software.Proofreading abilities.Working knowledge and experience
with applicable regulations 21 CFR, US FDA guidelines, ICH
guidelines, US, EU and AU regulatory agencies.Strong computer
skills in order to learn new programs as quickly as possible.
Experience in MS Word, Excel, Outlook and Adobe Acrobat is a
must.
Keywords: Amneal Pharmaceuticals, Hoboken , Regulatory Affairs Associate Iii, Other , Hoboken, New Jersey
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