Senior Manager, Regulatory Affairs

6 months ago

Princeton NJ, United States Sun Pharma (Taro Pharma) 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.

 

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.

  • Regulatory Affairs Senior Manager

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Unlock Your Potential in Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of regulatory documents to health authorities worldwide.Key...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

    Princeton, NJ, 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...

  • Regulatory Affairs Manager

    4 weeks ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job Title: Regulatory Affairs ManagerJob Summary: We are seeking a highly skilled Regulatory Affairs Manager to join our team at TK-CHAIN LLC. The successful candidate will be responsible for managing regulatory activities associated with planning, authoring, compiling, and submitting high-quality regulatory submissions to the FDA within company timelines...

  • Senior Manager, Regulatory Affairs

    5 months ago

    Princeton, United States Sun Pharma (Taro Pharma) 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...

  • Senior Manager, Regulatory Affairs Specialist

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Sun Pharmaceutical Industries, Inc. as a key member of our Regulatory Affairs team!We are seeking a highly skilled Senior Manager, Regulatory Affairs to handle publishing and coordinating tasks for Global RA submission activities. This role will support the Global RA submission process and infrastructure.Must be able to multi-task and coordinate for...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

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

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day One...

  • Senior Manager Regulatory Affairs

    1 month ago

    US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Manager, Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for handling publishing and coordinating tasks for Global RA submission activities.Key Responsibilities:Coordinate and...

  • Senior Manager, Regulatory Affairs

    5 months ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

  • Senior Manager, Regulatory Affairs

    5 months ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    Job DescriptionCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company...

  • Senior Manager, Regulatory Affairs

    5 months ago

    PRINCETON, United States Sun Pharma (Taro Pharma) Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

  • Senior Manager, Regulatory Affairs

    1 month ago

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

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

  • Senior Manager, Regulatory Affairs

    5 months ago

    Princeton, NJ, United States Sun Pharma (Taro Pharma) Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

  • Senior Manager, Regulatory Affairs

    2 months ago

    Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

  • Senior Manager, Regulatory Affairs

    1 month ago

    Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection - Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day One...

  • Senior Manager, Regulatory Affairs

    4 weeks ago

    Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection - Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day One...

  • Senior Manager, Regulatory Affairs

    1 month ago

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

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Do you have the skills to fill this role Read the complete details below, and make your application today.Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome...

  • Senior Manager Regulatory Affairs

    4 weeks ago

    US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Unlock Your Potential in Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of regulatory documents to health authorities worldwide.Key...

  • Sr. Director, Regulatory Affairs Strategy

    4 weeks ago

    Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy   The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

  • Sr. Director, Regulatory Affairs Strategy

    6 months ago

    Princeton, NJ, United States Sun Pharma (Taro Pharma) Full time

    Senior Director, Global Regulatory Affairs Strategy   The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

  • Director of Regulatory Affairs

    3 weeks ago

    Princeton, United States The Carolan Group Full time

    Job Title: Director/Senior Director of Regulatory Affairs – Global Regulatory Lead (Oncology)Location: Princeton, NJ OR Mountain View, CAOverview:Our client, a leader in innovative drug development, is seeking a strategic and experienced Director or Senior Director of Regulatory Affairs to join their Global Regulatory team. This role involves developing...