Manager of Regulatory Affairs

2 weeks ago


Denville, New Jersey, United States Ingenus Full time
Job Overview

As a Manager of Regulatory Affairs, you will play a pivotal role in ensuring compliance with regulatory standards and facilitating the approval process for pharmaceutical products.

Key Responsibilities:

· Prepare and evaluate various sections of ANDAs, NDAs, and address inquiries from the FDA.

· Develop strategies and assess Meeting Packages and Proprietary Name requests with minimal oversight for NDA submissions.

· Possess comprehensive knowledge and experience in reviewing and approving regulatory CMC documentation.

· Offer regulatory insights to cross-functional teams regarding product development, manufacturing, testing, and commercialization of complex drug products and dosage forms.

· Stay informed and proactively implement new regulations issued by the US FDA.

· Foster effective communication within internal and cross-functional teams by providing regular updates and addressing work-related challenges and successes.

· Manage the Electronic Submissions Gateway account and eCTD software.

· Experience in eCTD compilation is preferred.

· Undertake additional tasks as assigned by the supervisor.

Qualifications:

· A Bachelor's degree with over 8 years of experience in regulatory strategy and the submission of ANDAs and NDAs within the pharmaceutical sector.

· Practical experience with any e-CTD building software.

· Ability to manage multiple tasks in a dynamic environment with minimal supervision.

· Capability to work flexibly, organize personal workload, and effectively prioritize competing demands.

· Exceptional attention to detail and accuracy, consistently maintaining high-quality standards.

· Ability to cultivate and sustain effective working relationships with colleagues, supervisors, and clients.

· Openness to acquiring new skills and flexibility to meet business needs.

· Utilize knowledge and expertise to contribute to and enhance process improvements.



  • Denville, New Jersey, United States Salerno Duane Group Full time

    Job OverviewAutomotive Finance Operations ManagerWe are in search of a seasoned professional to become a part of our team as a Finance Operations Manager. The ideal candidate will possess a strong enthusiasm for automotive finance operations and a keen emphasis on regulatory compliance and product expertise. Key responsibilities encompass contract...


  • Denville, New Jersey, United States Salerno Duane Group Full time

    Job OverviewWe are seeking an experienced Financial Operations Manager to join our team at Salerno Duane Group. As a key member of our organization, you will be responsible for leading our Finance and Insurance (F&I) operations, driving business growth, and ensuring compliance with industry regulations.Key ResponsibilitiesBusiness Development: Identify and...


  • Denville, New Jersey, United States Nielsen Nissan of Denville Full time

    Nielsen Nissan of Denville is seeking a highly motivated and customer-focused individual to join our team as a Business Development Center (BDC) Manager and Representative. This is a fantastic opportunity to work in a dynamic and fast-paced environment, where you will play a key role in driving sales and customer satisfaction.Key Responsibilities:Manage and...


  • Denville, New Jersey, United States Ingenus Full time

    Job OverviewAs a Senior Specialist in Medical Information, you will play a pivotal role in supporting healthcare professionals, customers, and patients by managing medical inquiries and ensuring compliance with industry standards.Key Responsibilities· Provide expert telephone support to healthcare professionals, customers, and patients, addressing medical...


  • Denville, New Jersey, United States Biztech Inc Full time

    Position OverviewAs an Industrial Project Supervisor at Biztech Inc, you will be responsible for overseeing the installation processes and managing contractors involved in industrial equipment projects, including aftermarket refurbishments. Your role will emphasize quality assurance, comprehensive site documentation, and strict adherence to safety...


  • Denville, New Jersey, United States Prime Healthcare Full time

    OverviewAt Prime Healthcare, we pride ourselves on our unwavering commitment to excellence, empathy, and community service. We are currently looking for dedicated professionals to join our esteemed team.Our network encompasses highly rated healthcare facilities recognized for delivering safe, high-quality, and compassionate medical care. We serve diverse...


  • Denville, New Jersey, United States FellowshipLIFE, Inc. Full time

    Join Fellowship Medical Group, a division of FellowshipLIFE, where you'll thrive in a state-of-the-art medical environment. Enjoy the autonomy to practice medicine while benefiting from flexible schedules that promote work/life balance. Grow your leadership skills with opportunities for advancement in our expanding primary care and post-acute services. We're...


  • Denville, New Jersey, United States Nielsen Nissan of Denville Full time

    Job OpportunityNielsen Nissan of Denville is seeking skilled Automotive Technicians to join our team.Benefits Package:As a full-time, paid employee, you will participate in a comprehensive development program with the support of our experienced technicians and managers.Free Education Opportunity: Pursue a degree online or in-person with Strayer University,...


  • Denville, United States Ingenus Full time

    Job DescriptionJob Description·             Prepare and review various modules of ANDAs, NDAs, and responses to FDA queries.·             Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for NDA’s.·             In-depth knowledge and experience of regulatory CMC...

  • Facilities Manager

    3 months ago


    Denville, United States Celebrate The Children Inc Full time

    Job DescriptionJob DescriptionCelebrate the Children is seeking an experienced and dedicated Facilities Manager to oversee and manage the maintenance and operations of our school facilities. The ideal candidate will ensure that our environment remains safe, clean, and conducive to the educational needs of our students and staff. This role is crucial in...


  • Denville, United States Celebrate The Children Inc Full time

    Job DescriptionJob DescriptionCelebrate the Children is seeking an experienced and dedicated Land & Buildings Manager to oversee and manage the maintenance and operations of our school facilities. The ideal candidate will ensure that our environment remains safe, clean, and conducive to the educational needs of our students and staff. This role is crucial in...

  • Pharmacy Manager

    4 weeks ago


    Denville, United States CVS Health Full time

    Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we...

  • Cultivation Manager

    2 months ago


    Denville, United States Ascend Wellness Holdings Full time

    Job DescriptionJob DescriptionSUMMARYThe Cultivation Manager is responsible for successful cultivation activities from seed/clone through harvest, following company policies and procedures and in compliance with state regulationsPRIMARY RESPONSIBILITES Responsible for the grow operations, including developing a detailed plan and timeline for plant production...

  • Pharmacy Manager

    2 months ago


    Denville, United States CVS Health Full time

    Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we...


  • Denville, United States Ingenus Full time

    Job DescriptionJob Description · Provide phone support to health care professionals, customers and patients, involving receipt and tracking of medical inquiries, adverse events, product quality complaints, and other types of calls as required.· Receive and document incoming telephone calls, fax or emails from various sources including business partners...

  • Accounting Assistant

    2 weeks ago


    Denville, United States A great medical billing company! Full time $24 - $27

    Job DescriptionJob DescriptionJob Summary:We are seeking a detail-oriented and organized Staff Accountant to join our finance team. The ideal candidate will play a key role in maintaining accurate financial records, preparing financial reports, and supporting various accounting functions. This position is an excellent opportunity for individuals looking to...


  • Denville, United States Ascend Wellness Holdings Full time

    Job DescriptionJob DescriptionOVERVIEW: This position reports directly to the Packaging Manager and is responsible for a leading the production areas of packaging. The Packaging Supervisor completes their duties in compliance with the company policy, laws and rules governed by the state.ESSENTIAL DUTIES AND RESPONSIBILITIES:Lead and team members in areas...

  • Kitchen Associate

    3 months ago


    Denville, United States Ascend Wellness Holdings Full time

    Job DescriptionJob DescriptionJOB SUMMARYA Kitchen Associate is responsible for production of edible products. The Kitchen Associate performs their duties in compliance with company policy and food safety guidelines. This position reports to the Kitchen ManagerPRIMARY RESPONSIBILITES Follows the production schedule Track and weigh all ingredients accurately...

  • Apprentice Technician

    3 months ago


    Denville, United States Nielsen Nissan of Denville Full time

    Job DescriptionJob DescriptionNielsen Nissan of Denville is seeking Apprentice Technicians to join our Denville NJ team!BENEFITS:During your apprenticeship, you are a full-time, paid employee who will complete a development program with the support of our coaching technicians and managersFREE COLLEGE OPPORTUNITY! Online or in-person with Strayer...


  • Denville, United States Nielsen Nissan of Denville Full time

    Job DescriptionJob DescriptionNielsen Automotive Group has sales opportunities in our new location on Route 10 in Denville.  Two great franchises to sell from at the same location, both Nissan and Infiniti.  The best of both worlds being able to sell the high volume Nissan brand along with the Infiniti high-line brand. Immediate openings for the right...


  • Denville, United States Nielsen Nissan of Denville Full time

    Job DescriptionJob DescriptionNielsen Automotive Group has sales opportunities in our new location on Route 10 in Denville.  Two great franchises to sell from at the same location, both Nissan and Infiniti.  The best of both worlds being able to sell the high volume Nissan brand along with the Infiniti high-line brand. Immediate openings for the right...

  • Automotive Technician

    3 months ago


    Denville, United States Nielsen Nissan of Denville Full time

    Job DescriptionJob DescriptionNielsen Nissan of Denville is looking to add Automotive Mechanics to their team. These people will be accountable for repairing vehicles and ongoing maintenance for our loyal customers.The ideal candidates will have previous automotive experience working with a variety of engines, be reliable, exhibit teamwork, and add value to...


  • Denville, United States Nielsen Nissan of Denville Full time

    Job DescriptionJob DescriptionWhether you're in the automotive industry or joining us from another field, the Nielsen Nissan of Denville is ready to welcome you to our team!  The Nielsen Automotive Group prides itself on providing a safe, friendly, and productive work environment, exceeding our employees’ expectations giving them the opportunity to...


  • Denville, United States Nielsen Nissan of Denville Full time

    Job DescriptionJob DescriptionWhether you're in the automotive industry or joining us from another field, the Nielsen Nissan of Denville is ready to welcome you to our team!  This is a great earning opportunity with our newest Nissan and Infinity location.  Huge used car inventory and digital budget in place for lead opportunities.  The Nielsen...

  • Post-Harvest Associate

    3 months ago


    Denville, United States Ascend Wellness Holdings Full time

    Job DescriptionJob DescriptionJOB SUMMARYThe Post-Harvest Associate will be responsible for preparing and processing harvests for flower sales and oil extraction. The Post-Harvest Associate will also be responsible for equipment sanitization and sterilization as well as maintaining facilities cleanliness.PRIMARY RESPONSIBILITESManicuring cannabis in...


  • Denville, United States Ascend Wellness Holdings Full time

    Job DescriptionJob DescriptionJOB SUMMARYThis position is responsible for assisting in the cleaning, maintenance, and upkeep of the facility. The Custodian assists in routine and preventative maintenance, sanitation, and cleaning of all equipment within the facility, as well as general cleaning and upkeep of the facility itself. You are also a team player -...

  • 2nd Shift PM Mechanic

    2 months ago


    Denville, United States Ascend Wellness Holdings Full time

    Job DescriptionJob DescriptionThis position is responsible for assisting in the maintenance and upkeep of the facility. The Maintenance Technician assists in routine and preventative maintenance of all equipment within the facility, as well as general cleaning and upkeep of the facility itself. The ideal candidate is well-rounded, with some exposure to...


  • Denville, United States Ascend Wellness Holdings Full time

    Job DescriptionJob DescriptionThis position is responsible for assisting in the maintenance and upkeep of the facility. The Maintenance Technician assists in routine and preventative maintenance of all equipment within the facility, as well as general cleaning and upkeep of the facility itself. The ideal candidate is well-rounded, with some exposure to...