Manager/Sr. Manager

4 weeks ago


Trenton, United States CareerBuilder Full time

Summary
This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies.

Education and Credentials
Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.
RAC certification or other equivalent is preferred.

Experience

Minimum Bachelors degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience, at least 3 years of regulatory CMC experience with US product development.
Deep knowledge of US and EU regulations for biosimilars is preferred.
Deep knowledge of regulations for drugs and biologics.
Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.
Experience in various regulatory submissions and communication with regulatory agencies. Hosted communication with the agencies on clinical development plans, clinical design and other clinical aspects (including document package writing, meetings and discussions with the agency, etc.) is preferred.
Led at least one drug IND application in US and get it approved. Experience in endocrine drugs such as insulin and GLP-1 is preferred.
Experience in working in multi-culture/multi-countries environment is preferred.

Skills

Demonstrated ability to manage multiple and diverse projects concurrently.
Demonstrated ability to develop positive relationships and collaborations.
Strong analytical skills; a strategic thinker, planner, and implementer.
Ability to operate independently with minimal supervision.
Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities

Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package;
Participate as Global Product Strategy Lead in cross-functional teams, including but not limited to, contract research organizations (CROs), functional working groups, global regulatory team, submission team, product development team, to ensure compliance with regulatory requirements;
Author

Module 2 and 3 documents for regulatory filings such as INDs/ IMPDs/ CTAs/ MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards.
Drive the preparation and review of regulatory submissions, such as INDs, BLAs, MAAs, meeting packages to ICH member Health Agencies, and supplemental filings ensuring regulatory documents are written per guidelines and timelines.
Manage and track filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates.

#J-18808-Ljbffr



  • Trenton, United States Tris Pharma Full time

    Description Sr Project Manager, Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, timing + roles + responsibilities for prgms incl scale-up activities, process validation, post-validation changes + comm w/ FDA. Provide tech spt to manufacturing + packaging ops or other...


  • Trenton, United States Terumo Medical Corporation Full time

    This is a highly visible position one which offers a tremendous opportunity to learn and grow with Terumo Medical Corp.! The incumbent will have the opportunity to collaborate across multiple company departments and functions as well as play an integral part of charting the course for the company's future successes! Job Summary: Sr. Manager Compensation will...


  • Trenton, United States Bulbrite Industries Full time

    We are looking for a SR. Marketing Manager to lead our internal marketing communications team. This role would in essence run our internal agency with each of our sales verticals as their clients. They must be able to merchandise and market our product for different target customers and consumers. This role will be responsible for 360 degree marketing for...


  • Trenton, United States Datrose Full time

    Engineering, Architecture, Drafting/Design, Scientific Accounting & Finance, Information Technology Job Details Engineering Sr. Structural Engineer Warren, NJ Posted: 2/26/2024 Job Description Job ID#: 26726 Job Category: Engineering Position Type: Direct An engineering company located in Warren, NJ is seeking a Sr. Structural Engineer to join their team....


  • Trenton, United States Penn Technical Staffing Full time

    An engineering company located in Warren, NJ is seeking a Sr. Structural Engineer to join their team. The ideal candidate will have 8+ years of experience in building technologies with a PE license. Must be familiar with steel, concrete, masonry, and timber construction and building code requirements. Will be responsible for leading projects regarding the...


  • Trenton, United States Foster McKay Full time

    The Senior Financial Project Manager is responsible for developing and maintaining a world class project management function for the US Group Services Finance organization within company. In partnership with IT, Finance leadership and other key stakeholders, she/he will provide high quality leadership over Finance portfolio of projects, scope future...


  • Trenton, United States Torcon Full time

    Sr. Project Engineer Department: Engineering Employment Type: Full Time Location: Philadelphia Branch Reporting To: Project Executive/ Project Manager Description Torcon is seeking Project Engineers with 5 to 8 years of experience in the construction industry. The Project Engineer will be responsible for evaluation of submittals and RFI’s to support...

  • Sr. Accountant

    4 days ago


    Trenton, United States Foster McKay Full time

    “The only way to do great work is to love what you do. If you haven’t found it yet, keep looking. Don’t settle.” Our client is looking for a Sr. Accountant to assist in oversight of general accounting operations by controlling and verifying their financial transactions. Senior Accountant responsibilities include reconciling account balances,...


  • Trenton, United States Terumo Medical Corporation Full time

    Job Summary: The Sr. IT Support Specialist is responsible for administering and supporting the enterprise user community. This will involve working on the phone, in person and within the helpdesk system to process support requests, document solutions and communicate status to the end users and IT management. Additionally, this role is responsible for the...


  • Trenton, United States Tris Pharma Full time

    Description Tris Pharma, Inc. ( www.trispharma.com ) is a leading privately-owned biopharmaceutical company in the U.S . with a mission to develop and commercialize innovative therapeutics that address unmet patient needs. Our core focus is CNS, with a marketed portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical-stage programs...

  • Sr. Financial Analyst

    4 weeks ago


    Trenton, United States Lupin Pharmaceuticals Full time

    Overview: Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on womens health. Our first Research and Development facility in the US is located...


  • Trenton, United States TerraCycle Full time

    TerraCycle Overview TerraCycle is an international leader in innovative sustainability solutions, creating and operating first-of-their-kind platforms in recycling, recycled materials, and reuse. Operating in 20 countries, including 12 in Europe, TerraCycle works with manufacturers, retailers and end users to implement turnkey recycling programs through a...


  • Trenton, United States Crescens Full time

    Job title : Sr. Mainframe Developer (Lead) Location: Trenton NJ (Hybrid) Duration : 6+ months Type : ContractShort Description: SENIOR HANDS-ON developer with good communication & some lead exp. responsible for analysis, design, coding, component & assembly testing. Contractor will be involved in maintenance (incl prod. support) enhancement & development...


  • Trenton, United States United Fire & Casualty Full time

    UFG is currently hiring for a Sr. Commercial Lines Underwriter to join our team! The Senior Commercial Lines Underwriterwill manage a commercial underwriting territory of approximately $8 million - $14 million. The individual in this role will work hard to attain positive results (premium growth and acceptable loss ratios) through sound risk selection,...


  • Trenton, United States MSIG Holdings Inc Full time

    The Organizational Change Management Manager is responsible for developing, leading, and implementing comprehensive OCM strategies and activities that maximize the adoption of change and minimize resistance. This role will partner with business, IT, and Digital Transformation to provide focus on all aspects of change, including people, process, and...


  • Trenton, United States Tris Pharma Full time

    Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have...


  • Trenton, United States First American Financial Company Full time

    Closing Manager/Branch Manager page is loaded **Closing Manager/Branch Manager** **Closing Manager/Branch Manager** locationsUSA, New Jersey, East Windsor time typeFull time posted onPosted 7 Days Ago job requisition idR029611 ****Company Summary**** Join a team that puts its People First! First American's Direct division provides comprehensive title...

  • Manager

    4 weeks ago


    Trenton, United States Subway - 11548-0 Full time

    Job DescriptionJob DescriptionA SUBWAY® M.I.T (Manager in Training) greets and serves guests, prepares food, and maintains food safety and sanitation standards. Exceptional customer service is a major component of this position (and greatly boosts tip potential!) Full-Time and Part-Time positions available. M.I.T.'s are first in line to receive a...


  • Trenton, United States Environmental Waste Management Full time

    EWMA is a 100% employee-owned, New Jersey-based environmental consulting and remediation firm providing innovative and cost-effective solutions since 1987. We offer integrated environmental and engineering services for both public and private sector clients. EWMA is seeking a Project Manager that has a seller-doer mindset to manage our projects and find new...

  • Portfolio Manager

    1 week ago


    Trenton, United States Hays Full time

    Portfolio Manager | Commercial and Residential portfolio | New Jersey Your new company Hays Property have partnered with a successful New Jersey based owner and developer who are looking to hire a Portfolio Manager to oversee all aspects of property and asset management for the groups owned and developed assets. This is an exciting opportunity for...