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Senior Manager, Regulatory Affairs

3 months ago

Lawrenceville, United States Sun Pharmaceutical Industries, Inc. Full time

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.