Regulatory Affairs Associate

2 weeks ago

Overland Park, United States Parnell Veterinary Pharmaceuticals Full time

Who We Are

Parnell Veterinary Pharmaceuticals is a global animal health company based in Overland Park, KS with a focus on innovation and rapid growth. Our unique digital technologies integrate with our innovative products to provide veterinarians, producers and pet parents with unique solutions for their animal health needs. We offer personal and professional development opportunities for those who demonstrate the company's core values of Professionalism, Excellence, and Teamwork, and an exciting, fast-paced and entrepreneurial work environment.


We are seeking a Regulatory Affairs Associate to join our team The primary responsibility of the Regulatory Affairs Associate will be Regulatory and Chemistry, Manufacturing, and Controls (CMC) development activities in support of U.S. and ex-U.S. regulatory filings (e.g. INAD, NADA, ANADA) for both internal projects and with partners/alliances. This position provides development and CMC strategy and risk assessments. The incumbent will manage interactions and strategic negotiations with regulatory agencies and partners. This role will ensure US pharmacovigilance compliance with clinic follow-up and ADE reporting.


The incumbent will possess the skills to lead and collaborate effectively across the company, to align the broader Parnell organization to ensure compliance with the regulation guidance. The Regulatory Affairs department works as one team effectively collaborating with the Executive Leadership Team, Manufacturing, Quality Assurance, New Product Introduction, Commercial Operations, and Marketing to deliver our vision of being a growth-oriented, trusted and reliable resource, delivering innovative solutions to our customers’ success.


Responsibilities

  • Development and oversight of CMC strategy and risk assessments, ensuring compliance with U.S. and international regulatory requirements, including working on protocol and experimental designs.
  • Review, approval, and release of the CMC section of a high-volume of development and maintenance regulatory submissions. Support of drug substance and drug product dossiers are required. Submissions are recognized as high quality as demonstrated by limited review rounds and minimal Health Authority questions (FDA CVM, APVMA, CVMP, VDD), and one-pass approvability.
  • Work closely with Manufacturing to resolve complex CMC issues and to support process changes.
  • Develop, recommend, and communicate strategic direction and best possible regulatory position to achieve desired outcomes.
  • Effective review, approval, and release procedures assure that submissions are of the highest quality while meeting current Health Authority regulatory expectations and business needs according to defined timelines.
  • Interact and strategically negotiate with representatives from Regulatory Agencies to assure that appropriate and pragmatic positions can be negotiated with the highest probability of success.
  • Responsible for development of strategy and risk assessments for CMC activities. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities and risks are identified, communicated, and mitigated as necessary.
  • Maintains the expertise and positive image of CMC expert in an evolving regulatory environment.
  • Develops excellent working relationships with internal regulatory and external functional partners; including, vendors, partners, and collaborators.
  • Review of product labelling, advertisement, and marketing related product materials. Oversight of labelling development and/or changes with graphics vendors and/or CMOs. Prepare submissions and listings of labelling materials for FDA.
  • Work with team to establish department infrastructure and procedures for pre and post approval regulatory functions for veterinary pharmaceuticals.


Qualifications

Education:     

  • B.S. degree in chemistry, Animal Science, Life Science, Agriculture, or related field required.

Professional:

  • 3 – 5 years pharmaceutical regulatory experience desired.
  • Experience within the animal health pharmaceutical industry is desired.
  • Strong knowledge of the US FDA CVM guidance's is required.


The competitive remuneration package includes;

• 41 days PTO each year (22 x Vacation, 10 x Personal, 9 x Public Holidays)

• Quarterly Bonuses

• Annual Bonus

• A top-tier company funded Healthcare program

• 401K, immediately vested with a 4% match

  • Regulatory Affairs Associate

    2 weeks ago

    Overland Park, United States Parnell Veterinary Pharmaceuticals Full time

    Who We Are Parnell Veterinary Pharmaceuticals is a global animal health company based in Overland Park, KS with a focus on innovation and rapid growth. Our unique digital technologies integrate with our innovative products to provide veterinarians, producers and pet parents with unique solutions for their animal health needs. We offer personal and...

  • Regulatory Affairs Associate

    2 weeks ago

    Overland Park, United States Parnell Veterinary Pharmaceuticals Full time

    Who We Are Parnell Veterinary Pharmaceuticals is a global animal health company based in Overland Park, KS with a focus on innovation and rapid growth. Our unique digital technologies integrate with our innovative products to provide veterinarians, producers and pet parents with unique solutions for their animal health needs. We offer personal and...

  • Associate Regulatory Affairs-CMC

    1 week ago

    Newbury Park, United States Aequor Technologies Full time

    FULLY REMOTE The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...

  • Associate Director of Regulatory Affairs

    4 weeks ago

    Abbott Park, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Director of Public Policy

    3 weeks 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

  • Associate Regulatory Affairs-CMC

    2 weeks ago

    Newbury Park, United States Ampcus Incorporated Full time

    What we are looking for: Desire to learn Regulatory Affairs CMC and global submission strategy Strong organizational skills with attention to detail Proficient time management skills and ability prioritize workload Ability to work both independently and as a member of a team Proficient skills in Microsoft Office suite, especially Word, Excel,...

  • Senior Associate, Regulatory Affairs

    3 days ago

    Florham Park, United States Exeltis Full time

    Job Description Job Description Salary: 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...

  • Senior Associate, Regulatory Affairs

    3 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 & ResponsibilitiesCMC Regulatory Affairs Collaborate with different stakeholders of the company and procure documentation...

  • Director of Public Policy

    3 days ago

    Overland Park, United States CRH Full time

        Job ID:  494321   Ash Grove Cement, a CRH company, provides Portland and masonry cements to help build the foundation and infrastructure for the world around us.  We ship millions of tons of cement from our plants and network of terminals located across North America. When you work for Ash Grove, you are connecting to something bigger....

  • Senior Manager, Regulatory Affairs

    2 weeks ago

    Menlo Park, United States Meet Recruitment 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...

  • Regulatory & Medical Affairs

    22 hours ago

    Menlo Park, CA, United States Oruka Tx Full time

    About Us: Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We have a lead program that we expect will be in the clinic in 2025 and could offer transformative efficacy for a disease that affects millions of people. As we build our core team, we're seeking a Program Management leader who is not just looking for a job,...

  • Senior Manager, Regulatory Affairs

    3 weeks 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

    2 weeks 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 Manager, Regulatory Affairs

    1 week 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 Manager, Regulatory Affairs

    3 weeks 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...

  • Head of Regulatory Affairs and Quality

    4 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

    1 month ago

    Menlo Park, CA, United States Russell Solutions Group Full time

    Head of Regulatory Affairs and Quality About 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 all Regulatory Affairs...

  • Senior Manager, Rates and Regulatory Affairs

    4 days ago

    Litchfield Park, United States Liberty Utilities Full time

    Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) Liberty Utilities Senior Manager, Rates and Regulatory Affairs in Litchfield Park , Arizona Senior Manager, Rates and Regulatory Affairs Litchfield Park, AZ, US,...

  • Principal Regulatory Affairs Strategist

    2 months 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 Regulatory Affairs

    2 months 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...