• Regulatory Affairs Associate

    Amneal Pharmaceuticals (Piscataway, NJ)
    *Description:* * The Regulatory Affairs Associate III, independently prepares, reviews without appreciable direction and submits high quality, regulatory ... Affairs * **Organization:** **Scientific Affairs * **Title:** * Regulatory Affairs Associate III* **Location:** *NJ-Piscataway* **Requisition… more
    Amneal Pharmaceuticals (05/23/20)
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  • Regulatory Affairs Associate

    Amneal Pharmaceuticals (Brookhaven, NY)
    *Description:* * The Regulatory Affairs Associate II, with minimal guidance, prepares, reviews and submits high quality, regulatory submissions such as ... guidelines and applicable federal laws. *Essential Functions:* * The Regulatory Affairs Associate II, with...to detail, while meeting deadlines for assigned projects. - Advanced * Excellent written and verbal communication skills and… more
    Amneal Pharmaceuticals (07/07/20)
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  • Associate Director, Regulatory

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …issues. + Prepare and review annual reports and supplements for marketed products. The Associate Director, Regulatory Affairs will liaise with the review ... BS preferably in a scientific discipline. + Preferred: an advanced degree (Masters, Pharm.D., Ph.D.). + With advanced...or any other characteristic protected by law. **Job Title:** Associate Director, Regulatory Affairs Strategy… more
    Daiichi Sankyo Inc. (07/10/20)
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  • Regulatory Affairs Associate

    Catalent Pharma Solutions (Harmans, MD)
    …at Catalent? Start here Position Summary Catalent Gene Therapy is looking to recruit a Regulatory Affairs Associate II to join our growing team in Harmans, ... millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical,...MD. Regulatory Affairs Associate II is… more
    Catalent Pharma Solutions (07/07/20)
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  • Senior Associate Director…

    Boehringer Ingelheim (Ridgefield, CT)
    …benefits our employees, patients and communities. **Senior Associate Director / Associate Director, CMC Regulatory Affairs - Biologics** **_Candidate ... AD:** + Minimum BS/BA Chemistry orBiology or Pharmaceutical Science, advanced degree preferred + With BS/BA: 8 years workexperience...Pharma/BI USA_ **Title:** _Senior Associate Director / Associate Director, CMC Regulatory Affairs more
    Boehringer Ingelheim (06/20/20)
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  • Associate Director of Regulatory

    Athenex (Schaumburg, IL)
    Associate Director of Regulatory Affairs Schaumburg, IL, United States Full Time Apply for position now Athenex, Inc., a specialty oncology pharmaceutical ... team and is searching for a Assoc. Director, Regulatory Affairs . This individual will operate in...Skills and Experience .Bachelor's degree in life sciences required; advanced degree preferred .Minimum of 10 years pharmaceutical industry… more
    Athenex (08/01/20)
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  • Associate Director, Regulatory

    BD (Becton, Dickinson and Company) (Covington, GA)
    # Job Description Summary # Job Description The Associate Director, Regulatory Affairs is a key leadership role in the Division and is responsible for ... or quality systems including 5 years of personnel management experience + Regulatory Affairs Certification \(RAC\), advanced Degree and Certifications… more
    BD (Becton, Dickinson and Company) (07/18/20)
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  • Associate Director, Regulatory

    Intercept Pharmaceuticals (San Diego, CA)
    …Intercept is among the leading companies focused on the disease. POSITION SUMMARY: The Associate Director, Regulatory Affairs , will provide regulatory ... regulatory experience; 6 years with a MS or advanced degree. + Solid understanding of/experience in quality systems...in a growing, diverse and inclusive work environment! Keyword: Associate Director, Regulatory Affairs From:… more
    Intercept Pharmaceuticals (08/01/20)
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  • Associate Director Regulatory

    Bristol Myers Squibb (Jersey City, NJ)
    …every treatment we pioneer. Join us and make a difference. **POSITION** Director, Regulatory Affairs **SUPERVISOR** Senior or Executive Director, Regulatory ... Affairs **DEPARTMENT** Global Regulatory Affairs PREREQUISITES Bachelors in scientific discipline; A minimum of 10 years pharmaceutical industry experience in… more
    Bristol Myers Squibb (06/20/20)
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  • Associate Director, Commercial…

    Bristol Myers Squibb (Princeton, NJ)
    …and make a difference. The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert ... regulatory advice and risk assessment for the development of...risk assessment and mitigation strategies to Commercial Teams, Medical Affairs , Public Affairs , Value Access and Payment,… more
    Bristol Myers Squibb (07/28/20)
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  • Regulatory Affairs Associate

    United Therapeutics (Durham, NC)
    …senior level position, 5 years in the biopharmaceutical industry with 3 years in a regulatory affairs -CMC role or advanced degree and equivalent level of ... industry and regulatory affairs -CMC experience. + Excellent organizational, multitasking, and communication skills. + Proficiency with MS Office suite. + Ability… more
    United Therapeutics (06/20/20)
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  • Associate Manager, Regulatory

    Regeneron Pharmaceuticals (Tarrytown, NY)
    The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects related to ... Scientific degree required. 2-3 years of pharmaceutical industry experience in regulatory affairs ; experience in oncology preferred Knowledge of US FDA… more
    Regeneron Pharmaceuticals (07/18/20)
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  • Associate Director Regulatory

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …write regulatory documents in highly complex technical areas. **Job Title:** Associate Director Regulatory Affairs CMC **City:** Basking Ridge ... structure-guided R&D center in Berkeley, CA. **Job Summary:** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team… more
    Daiichi Sankyo Inc. (05/12/20)
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  • Associate Director US Regulatory

    Bayer (Whippany, NJ)
    …passion of our employees to innovate and give them the power to change.** ** Associate Director US Regulatory Affairs ** **YOUR TASKS AND RESPONSIBILITIES** ... The primary responsibilities of this role, Associate Director, Upper Respiratory Regulatory Affairs...an incumbent who possesses the following: Required Qualifications: + Advanced degree in life sciences with a minimum of… more
    Bayer (08/04/20)
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  • Associate Director/Director,…

    Editas Medicine (Cambridge, MA)
    …communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs and senior management, as relevant. + Ensure that ... Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10+ years'...with a minimum of 10+ years' experience in drug development/ regulatory affairs . + Experience with both US… more
    Editas Medicine (07/30/20)
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  • Regulatory Affairs Associate

    Fresenius Medical Center (Waltham, MA)
    …and prepares appropriate responses to such requests. + Reviews and advises Regulatory Affairs project team representatives on labels, labeling, protocols, ... Openings** 1 **PURPOSE AND SCOPE:** Assists with preparation of regulatory strategies and submissions required to market new or...+ 2 - 5 years' related experience; or an advanced degree without experience; or equivalent directly related work… more
    Fresenius Medical Center (07/19/20)
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  • Associate Manager CMC Regulatory

    Regeneron Pharmaceuticals (Rensselaer, NY)
    This position in CMC Regulatory Affairs involves the ability to support and provide some management to guide the Industrial Operations and Product Supply (IOPS) ... the decision-making process. This position will support all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs...a BS/BA with 5 years CMC experience or an advanced degree in life sciences with 2 years experience,… more
    Regeneron Pharmaceuticals (06/30/20)
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  • Director, Regulatory Affairs CMC

    Abbvie (North Chicago, IL)
    …and LinkedIn at https://www.linkedin.com/company/abbvie . The Director Regulatory Affairs , Chemistry, Manufacturing and Controls ... applications, supplements and variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research and… more
    Abbvie (07/29/20)
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  • Staff Regulatory Affairs Specialist…

    BD (Becton, Dickinson and Company) (Baltimore, MD)
    …these submissions\. The associate in this position is seen as a regulatory affairs subject matter expert\. For post\-market will provide regulatory ... an organization\. **Assets:** + Advanced degree \(MS, Ph\.D\., etc\.\) + RAPS Regulatory Affairs Certification \(RAC\) + Direct experience with US Class I,… more
    BD (Becton, Dickinson and Company) (07/31/20)
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  • Associate Director, Regulatory

    Regeneron Pharmaceuticals (Tarrytown, NY)
    …objectives within agreed timelines ensuring compliance is maintained with all regulatory commitments/requirements. **In this role, a typical day might include the ... company and FDA and other health authorities for assigned programs Develop regulatory strategies for assigned programs, in order to support Regeneron's development… more
    Regeneron Pharmaceuticals (07/18/20)
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