Senior Manager, Regulatory Affairs
Company: Sun Pharmaceutical Industries, Inc.
Location: Hightstown
Posted on: October 20, 2024
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Job Description:
COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA
EMPLOYEE!
Hybrid work arrangement
Medical, Dental, Vision Benefits
Health Savings Account (HSA), Flexible Spending Account (FSA)
Prescription Drug Coverage
Telehealth and Behavior Health Services
Income Protection - Short Term and Long Term Disability
Benefits
Retirement Benefits - 401k Company Match on Day One (100% vesting
immediately)
Group Life Insurance
Wellness Programs
Corporate Discounts on personal services: Cellular phones,
Entertainment, and Consumer Goods!
Sun Pharma Vision: Reaching People And Touching Lives Globally As A
Leading Provider Of Valued Medicines
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth
largest specialty generic pharmaceutical company in the world with
global revenues of over $ 4.5 billion US Dollars. Supported by more
than 40 manufacturing facilities, we provide high-quality,
affordable medicines, trusted by healthcare professionals and
patients, to more than 100 countries across the globe including the
United States. Sunology is a combination of Sun Values and Ideology
and is the way of life at Sun Pharma. Sunology is
Humility.Integrity.Passion.Innovation. It represents our promise to
all stakeholders including patients, physicians, and employees.
Our Code of Conduct
Our Global Code of Conduct governs every aspect of our operations.
Sun Pharma is a family of thousands of people, working across many
countries, speaking multiple languages, and all united, with one
common purpose: to make good health accessible and affordable to
local communities and society at large. Through active fieldwork,
dedicated research teams, and in recognition of the efforts who
work behind the scenes to combat illness and disease, the Sun
Pharmaceutical Group helps as many people as possible, to secure
their right to good health. The way we work every day is important
to us.
DOWNLOAD OUR CODE OF CONDUCT
The Senior Manager, Regulatory Affairs will handle publishing and
coordinating tasks for Global RA submission activities. Support the
Global RA submission process and infrastructure.
Must multi-task and coordinate for various programs and projects
for which SPARC GRA/ GRO is responsible.
Must understand and be updated with current Global Regulatory
filing requirements and eCTD structure.
Collaborate with Strategists (Leads), Publishers and various
stakeholders on submission strategies.
Track and schedule submission activity (i.e. status, audit trails)
and provide reports to upper management.
Validate and QC of incoming and outgoing regulatory
data/documents.
Archival of other necessary submissions and/or documents.
Review and QC final published submission documents before
submitting to Health Authority (QC with respect to publishing
aspects of the eCTD requirement).
Review and track the archiving of global eCTDs , paper submissions
and Health Authority correspondences using Regulatory Affairs
systems/tool.
Support, maintain and update authoring templates.
Assist functional areas with document-level requirements and best
practice techniques for compliant authoring.
Participate in infrastructural activities i.e, support
implementation of new tool/ systems required by department and/or
maintenance activities and enhancements.
Track, generate and present Monthly snapshots and/or yearly metrics
as applicable.
Support in maintenance and update Health Authority Commitment
tracker including post approval commitment for the programs
assigned to SPARC GRA/GRO and notify to the involved stakeholders
which includes but not limited to the following
Annual Report's
DSUR's
PBRER's
PADER's
PSUR's
Studies (if applicable)
Implement best practices, participate in process improvements /
enhancements within GRA/ GRO.
Participate in writing of or review new procedures or revising
existing procedures from time to time as requested by the
Functional / Department Head.
Coordinate internal, cross-functional or external meetings and the
necessary trainings, as per the requirement.
Undertake publishing activities for NDAs, INDs, MAAs, CTAs,
510(k)s, Orphan applications, Pediatric Study Plans, Pediatric
Investigational Plans, Fast Track/Breakthrough Therapy
Designations, Promotional materials etc as requested/ applicable
and assigned from time to time.
Publish, review, submission and archival of assigned global eCTDs
and paper submissions using Regulatory Affairs systems/tool.
Publishing includes;
eSub Prep (Bookmarking; hyperlinking; ensuring PDF is as per HA
guidelines)
Submission level publishing
Must have eCTD publishing experience
Qualifications include:
Associate or Bachelor's Degree required
Experience: 3-5 years' experience
Specialized knowledge : Publishing and related tools/ eCTD
requirements
Skills: Effective timeline management and communications relative
to submission components
Abilities: Flexible with strong spoken and written communications
skills and is able to navigate and work in a diverse cross
cultural/cross functional environment.
Keywords: Sun Pharmaceutical Industries, Inc., Hoboken , Senior Manager, Regulatory Affairs, Executive , Hightstown, New Jersey
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