Senior Manager, Regulatory Affairs
Company: Sun Pharma
Location: Princeton Junction
Posted on: July 8, 2025
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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. 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 Pharma, Vineland , Senior Manager, Regulatory Affairs, Healthcare , Princeton Junction, New Jersey