Senior Manager, Regulatory Affairs
Company: Sun Pharmaceutical Industries, Inc.
Location: Princeton
Posted on: September 24, 2024
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
MedicinesSun 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 ConductOur 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. -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 experienceQualifications 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., Trenton , Senior Manager, Regulatory Affairs, Executive , Princeton, New Jersey
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