Senior Associate, Regulatory Affairs

2 weeks ago

Florham Park, United States Exeltis Full time
Job DescriptionJob DescriptionSalary:

Role Overview

In this role, you will be responsible for assisting the Senior Manager of Regulatory Affairs and other team members in various Regulatory-related tasks mentioned below.

Primary Duties & Responsibilities

CMC Regulatory Affairs

  • Collaborate with different stakeholders of the company and procure documentation required for regulatory submissions, ensuring that departmental timelines are met.
  • Support the creation and review of technical documents for accuracy and acceptability for use in new ANDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
  • Review and approve change controls and assess their impact on the business based on an advanced understanding of regulatory guidelines and applicable FDA laws.

Labeling and Promotional Review:

  • Preparation of various regulatory Labeling submissions
  • Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
  • Prepare and submit updated labeling in eCTD format to the FDA.
  • Review labeling revisions and private label products.
  • Initiate and provide approval for change controls related to Artwork and labeling.
  • Ability to work on SPL Labeling

Regulatory-Operations:

  • Manage tracking and filing FDA correspondence, including phone calls, emails, and relevant documents.
  • Work with cross-functional teams to support regulatory activities for drug product submission.
  • Accurately update and maintain spreadsheets and databases in a timely manner.
  • Responsible for writing and/or reviewing Modules in eCTD and verifying proper hyperlinking and ensure navigational tools are functional.
  • Publishing and compiling documents while maintaining adherence to FDA standards and internal requirements.
  • Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

Additional Duties & Responsibilities

  • Trained and supports staff in the preparation of electronic drug listing information (SPL, PLR) to the FDA.
  • Process documents, prepare, assemble, compile and publish regulatory submissions in Electronic Common Technical Documents format (eCTD) as required.

Competencies/Career level

Innovation, entrepreneurial attitude, team leadership, adaptability/flexibility, results-oriented, Self-development.

  • Experienced user of various ECTD and SPL software
  • Superior communication, research and writing skills.
  • Attended a host of GMP training classes and Regulatory/Compliance Seminars and Webinars presented by professional organizations such as GPhA and RAPS affiliates.

Requirements and personal skills

  • Education: Minimum of a bachelor’s degree in a life science, pharmacy-related curriculum and/ or Advanced degree related to Manufacturing, Chemical, Pharmaceutical, Biological- Sciences. (RAC- Certification is a plus)
  • Languages: English, Spanish Language a Plus
  • Experience (years/area): 2+ Years in the Generic Pharmaceutical Industry with at least 1 year in Regulatory Affairs
  • Specific Knowledge: Regulatory Affairs general practices for generic drugs, FDA guidance's
  • Travel: Minimal
  • Personal skills: General management skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them successfully.

Physical Demands

This job operates in a remotely in a professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc. 


Travel:  No


Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m. 

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  The employee:

  • Is required to interact with internal and external contacts independently.
  • Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
  • Is desk-based and may be sitting for long periods of time. Ergonomically work from a chair for 8+ hours per day.
  • Constantly utilize a computer monitor screen, trying to minimize stress on vision.
  • Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
  • Must communicate clearly: phone calls, emails, in-person conversations.
  • Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.

 

  • Senior Manager, Regulatory Affairs

    1 day ago

    Menlo Park, United States Meet Full time

    Senior Manager, Regulatory Affairs *Hybrid Role - Menlo Park, CA* Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support...

  • Senior Manager, Regulatory Affairs

    3 days ago

    Menlo Park, United States Meet Full time

    Senior Manager, Regulatory Affairs*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support their...

  • Senior Director Regulatory Affairs

    3 weeks ago

    Menlo Park, United States Meet Full time

    Exciting Opportunity in Regulatory Affairs - Sr. Director Location: Redwood City, CA (Onsite 3 days per week)Company Overview:A pioneering biotechnology company, at the forefront of cortisol modulation research and development, is seeking a dynamic Regulatory Affairs Sr. Director to join their innovative team. With a robust pipeline of over 1,000 selective...

  • Senior Director, Regulatory Affairs, Ad/Promo

    3 days ago

    Menlo Park, United States Meet Full time

    Senior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...

  • Senior Director, Regulatory Affairs, Ad/Promo

    3 days ago

    Menlo Park, United States Meet Full time

    Senior Director, Regulatory Affairs - Advertising and Promotion*Hybrid Role - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Director of Regulatory Affairs,...

  • Head of Regulatory Affairs and Quality

    3 weeks ago

    Menlo Park, United States Russell Solutions Group Full time

    Job DescriptionJob DescriptionHead of Regulatory Affairs and QualityAbout This Role:We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of regulatory submissions. The incumbent will drive...

  • Head of Regulatory Affairs and Quality

    2 weeks ago

    Menlo Park, United States Russell Solutions Group Full time

    Job DescriptionJob DescriptionHead of Regulatory Affairs and QualityAbout This Role:We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of regulatory submissions. The incumbent will drive...

  • Scientific Director, Medical Affairs- CNS/Psychiatry

    2 weeks ago

    Florham Park, United States AbbVie, Inc Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...

  • Medical Director, Medical Affairs- CNS/Psychiatry

    2 weeks ago

    Florham Park, United States AbbVie, Inc Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...

  • Principal Regulatory Affairs Strategist

    4 weeks ago

    Deer Park, Texas, United States Danaher Full time

    Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.Our associates know...

  • Director of Public Policy

    5 days ago

    Overland Park, United States CRH plc Full time

    The role of a Director of Public Policy & Regulatory Affairs in the cement industry involves managing and enhancing relationships with government entities, regulatory bodies, and relevant stakeholders to ensure compliance with regulations and promote Regulatory Affairs, Director, Regulatory, Policy, Remote, Government, Manufacturing, Business Services

  • Director of Regulatory Affairs

    4 weeks ago

    Winter Park, Florida, United States Full Sail University Full time

    If you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewardingThis position will report to the...

  • Director of Regulatory Affairs

    4 weeks ago

    Winter Park, United States Full Sail University Full time

    If you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewarding!This position will...

  • Senior Manager, Regulatory Operations

    5 days ago

    Menlo Park, United States Meet Full time

    Senior Manager, Regulatory Operations This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects.Responsibilities...

  • Scientific Director, Medical Affairs- CNS/Psychiatry

    3 weeks ago

    Florham Park, New Jersey, United States AbbVie Full time

    Job Description *Position can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of clinical and...

  • Medical Director, Medical Affairs- CNS/Psychiatry

    3 weeks ago

    Florham Park, New Jersey, United States AbbVie Full time

    Job Description Provides medical, scientific, strategic and operational leadership and expertise into core medical affairs activities such as: generation of clinical and scientific data) (enhancing therapeutic benefit, safety, and value) health-care professional and provider collaborations and interactions;); medical education, scientific communications...

  • Regulatory Operations Coordinator

    2 days ago

    Elkins Park, United States Piper Companies Full time

    Piper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA . Responsibilities for the Regulatory Operations Coordinator include: Work with internal teams and stakeholders to build IND & CTA dossier content plans...

  • Senior Regulatory Strategy Consultant

    4 weeks ago

    Menlo Park, California, United States ReCode Therapeutics Full time

    Who We Are:ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...

  • Senior Regulatory Strategy Consultant

    4 weeks ago

    Menlo Park, United States ReCode Therapeutics Full time

    Who We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...

  • Senior Tax Associate

    2 weeks ago

    Florham Park, United States Wiss and Company LLP Full time

    Wiss is seeking a Senior Tax Associate, High Net Worth to join their growing Tax Practice in Florham Park, NJ. The candidate will have the opportunity to work closely with Tax leadership on supporting our High Net Worth and Ultra High Net Worth client base and serve as an integral member of our overall Family Office offering. This position will reside in...