Jobs
>
Étreux

    Associate Director, Regulatory Affairs - Boston, United States - Proclinical Staffing

    Proclinical Staffing
    Proclinical Staffing Boston, United States

    2 weeks ago

    Default job background
    Full time
    Description

    Associate Director, Regulatory Affairs - Boston, MA - Permanent

    Proclinical is seeking a strategic regulatory leader to join a renowned biotech. This is a permanent position located in Boston, MA.

    Primary Responsibilities:

    The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of finished products and uphold high standards of compliance for transportation, storage, and commercial distribution. The role also involves providing quality support to commercial affiliates and overseeing in-country distribution and Global Logistics providers, including Quality KPI and metrics reporting.

    Skills & Requirements:

    • B.S and/or M.S. degree, advanced degree or education in a scientific field is a plus.
    • Comprehensive knowledge of the drug development process.
    • Demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc).
    • Experience in oncology or rare disease.

    The Associate Director will:

    • Develop and execute innovative regulatory strategies for our development programs, including the implementation of non-clinical and clinical regulatory strategy for relevant products.
    • Lead the preparation and submission of high-quality domestic and global regulatory submission documents.
    • Communicate with global regulatory authorities and lead the preparation and conduct of meetings with health authorities.
    • Integrate knowledge of current legislation, guidelines, and other regulatory intelligence into the development strategies and ensure compliance with regulatory filing and reporting requirements.
    • Proactively identify regulatory opportunities and risks and propose alternative approaches and mitigations to resolve development program challenges.
    • Plan and obtain regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations.

    If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) or .

    Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

    Proclinical Staffing is an equal opportunity employer.

  • Pharvaris

    Regulatory Affairs Manager

    2 weeks ago

    Pharvaris Boston, United States

    Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients ...

  • Pharvaris

    Regulatory Affairs Manager

    3 weeks ago

    Pharvaris Boston, United States

    Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients ...

  • Pharvaris

    Regulatory Affairs Manager

    6 days ago

    Pharvaris Boston, United States

    Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients ...

  • The Judge Group

    Regulatory Affairs Director

    3 weeks ago

    The Judge Group Boston, United States

    About the Job · The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMIs unparalleled global portfolio of assay products, including companion diagn ...

  • Verily

    Head of Regulatory Affairs

    3 weeks ago

    Verily Boston, United States

    Who We AreVerily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We a ...

  • Foundation Medicine

    Regulatory Affairs Director

    2 weeks ago

    Foundation Medicine Boston, United States

    Job Description · About the Job · The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, includ ...

  • Katalyst Healthcares and Life Sciences

    Regulatory Affairs Specialist

    22 hours ago

    Katalyst Healthcares and Life Sciences Boston, United States

    Responsibilities: · Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations. · Cultivate relationships within Customer Operations, throughout the Company and with external stakeholders. Partner with Corporate Affairs, Rate Engineeri ...

  • Fairway Consulting Group

    Head of Regulatory Affairs

    1 week ago

    Fairway Consulting Group Boston, United States

    Our client is a Non-profit organization. They have asked us to assist them in their search for a · Head of Regulatory Affairs. · Major tasks and responsibilities include: · Oversees regulatory strategies and operations interactions for entire portfolio. · Manages and improves r ...

  • Imbria Pharmaceuticals

    Director, Regulatory Affairs

    2 weeks ago

    Imbria Pharmaceuticals Boston, United States

    Company Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiova ...

  • Imbria Pharmaceuticals

    Director, Regulatory Affairs

    2 weeks ago

    Imbria Pharmaceuticals Boston, United States

    Company Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...

  • White Collar Technologies, Inc

    Regulatory Affairs Associate

    2 weeks ago

    White Collar Technologies, Inc Boston, United States

    Job Description · Job Description · Job Description · We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting s ...

  • Fairway Consulting Group

    Head of Regulatory Affairs

    1 week ago

    Fairway Consulting Group Boston, United States

    Our client is a Non-profit organization. They have asked us to assist them in their search for a Head of Regulatory Affairs.Major tasks and responsibilities include:Oversees regulatory strategies and operations interactions for entire portfolio.Manages and improves regulatory doc ...

  • Halloran Consulting Group

    Consultant, Regulatory Affairs

    1 day ago

    Halloran Consulting Group Boston, United States

    Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran's Regulatory team in the Consultant, Regulatory Affairs role today · In this role, you will partner with client companie ...

  • KP Recruiting Group

    Regulatory Affairs Director

    1 week ago

    KP Recruiting Group Boston, United States

    Job Description · KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world's leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements across the United States. We rep ...

  • Vaco

    Regulatory Affairs Representative

    2 weeks ago

    Vaco Boston, United States

    Vaco has partnered with our client to hire a Regulatory Contractor for a month assignment. · Where: 100% Remote · When: Immediate need, 12+ month contract · Pay: $39-40/hour · Responsibilities:Responsible for providing regulatory content of label copy for all products. · Act ...

  • Discera Search

    Head of Regulatory Affairs

    6 days ago

    Discera Search Boston, United States

    Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next. · Be the go for all things regulatory and acti ...

  • INTELLECTT INC

    Regulatory Affairs Associate

    2 weeks ago

    INTELLECTT INC Boston, United States

    Role: Regulatory Affairs Associate · Location: Remote · Duration: 7 Months · Main Responsibilities · Provide regulatory input to product lifecycle planning. Assist in SOP development and review. · Assist in the development of regional regulatory strategy and update strategy ...

  • Halloran Consulting Group

    Consultant, Regulatory Affairs

    1 hour ago

    Halloran Consulting Group Boston, United States

    Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Hallorans Regulatory team in the Consultant, Regulatory Affairs role today · In this role, you will partner with client companies ...

  • Katalyst Healthcares and Life Sciences

    Regulatory Affairs Specialist

    2 weeks ago

    Katalyst Healthcares and Life Sciences Boston, United States

    Responsibilities: Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations. · Cultivate relationships within Customer Operations, throughout the Company and with external stakeholders. Partner with Corporate Affairs, Rate Engineering ...

  • Imbria Pharmaceuticals

    Director, Regulatory Affairs

    1 week ago

    Imbria Pharmaceuticals Boston, United States

    Company Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovas ...