Senior Manager, Regulatory Affairs Position Available In Mercer, New Jersey

Job Description:

Come Work for Us•Investing in You as A Sun Pharma Employee!

Hybrid work arrangement Medical, Dental, Vision Benefits HealthSavings Account (HSA), Flexible Spending Account (FSA) PrescriptionDrug Coverage Telehealth and Behavior Health Services IncomeProtection•Short Term and Long Term Disability BenefitsRetirement Benefits•401k Company Match on Day One (100% vestingimmediately) Group Life Insurance Wellness Programs CorporateDiscounts on personal services: Cellular phones, Entertainment, andConsumer Goods!

Sun Pharma Vision:

Reaching People And TouchingLives Globally As A Leading Provider Of Valued Medicines SunPharmaceutical Industries Ltd. (Sun Pharma) is the fourth largestspecialty generic pharmaceutical company in the world with globalrevenues of over $ 4.5 billion US Dollars. Supported by more than40 manufacturing facilities, we provide high-quality, affordablemedicines, trusted by healthcare professionals and patients, tomore than 100 countries across the globe including the UnitedStates. Sunology is a combination of Sun Values and Ideology and isthe way of life at Sun Pharma. Sunology isHumility.

Integrity.

Passion.

Innovation. It represents our promise toall stakeholders including patients, physicians, and employees. OurCode of Conduct Our Global Code of Conduct governs every aspect ofour operations. Sun Pharma is a family of thousands of people,working across many countries, speaking multiple languages, and allunited, with one common purpose: to make good health accessible andaffordable to local communities and society at large. Throughactive fieldwork, dedicated research teams, and in recognition ofthe efforts who work behind the scenes to combat illness anddisease, the Sun Pharmaceutical Group helps as many people aspossible, to secure their right to good health. The way we workevery day is important to us. The Senior Manager, RegulatoryAffairs will handle publishing and coordinating tasks for Global RAsubmission activities. Support the Global RA submission process andinfrastructure. Must multi-task and coordinate for various programsand projects for which

SPARC GRA/ GRO

is responsible. Mustunderstand and be updated with current Global Regulatory filingrequirements and eCTD structure. Collaborate with Strategists(Leads), Publishers and various stakeholders on submissionstrategies. Track and schedule submission activity (i.e. status,audit trails) and provide reports to upper management. Validate andQC of incoming and outgoing regulatory data/documents. Archival ofother necessary submissions and/or documents. Review and QC finalpublished submission documents before submitting to HealthAuthority (QC with respect to publishing aspects of the eCTDrequirement). Review and track the archiving of global eCTDs ,paper submissions and Health Authority correspondences usingRegulatory Affairs systems/tool. Support, maintain and updateauthoring templates. Assist functional areas with document-levelrequirements and best practice techniques for compliant authoring.

Participate in infrastructural activities i.e, supportimplementation of new tool/ systems required by department and/ormaintenance activities and enhancements. Track, generate andpresent Monthly snapshots and/or yearly metrics as applicable.

Support in maintenance and update Health Authority Commitmenttracker including post approval commitment for the programsassigned to SPARC GRA/GRO and notify to the involved stakeholderswhich includes but not limited to the following Annual Report’sDSUR’s PBRER’s PADER’s PSUR’s Studies (if applicable) Implementbest practices, participate in process improvements / enhancementswithin

GRA/ GRO.

Participate in writing of or review new proceduresor revising existing procedures from time to time as requested bythe 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 StudyPlans, Pediatric Investigational Plans, Fast Track/BreakthroughTherapy Designations, Promotional materials etc as requested/applicable and assigned from time to time. Publish, review,submission and archival of assigned global eCTDs and papersubmissions using Regulatory Affairs systems/tool. Publishingincludes; eSub Prep (Bookmarking; hyperlinking; ensuring PDF is asper HA guidelines) Submission level publishing Must have eCTDpublishing experience Qualifications include: Associate orBachelor’s Degree required

Experience:

3-5 years’ experienceSpecialized knowledge : Publishing and related tools/ e

CTDrequirements Skills:

Effective timeline management andcommunications relative to submission components

Abilities:

Flexible with strong spoken and written communications skills andis able to navigate and work in a diverse cross cultural/crossfunctional environment.