Senior Director Regulatory Affairs

3 weeks ago

Miami, United States Meet Full time

Senior Director, Regulatory Affairs (Generalist) Remote Position for West Coast-based candidates, frequent travel to Bay Area required Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Our client recently reported positive P3 data for their lead drug candidate and is in the process of filing an NDA this year. Key Responsibilities: Carry out Reg Strategy and Reg CMC functions to support major Regulatory submissions Serve as a cross-functional leader within the organization to facilitate prompt and accurate regulatory documentation Key Qualifications/Requirements 12+ years of Regulatory Affairs (mix of Clinical Reg and Reg CMC highly preferred) NDA/late stage experience highly preferred Non-oncology experience required, rare disease preferred Small molecule development experience required Startup experience highly preferred Please feel free to reach out directly to ...@peoplewithchemistry.com to discuss the details further

#J-18808-Ljbffr

  • Senior Regulatory Affairs Specialist

    6 days ago

    Miami Lakes, United States DemeTech Full time

    DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...

  • Senior Regulatory Affairs Specialist

    2 months ago

    Miami Lakes, United States DemeTECH Corporation Full time

    DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Miami Lakes, United States DemeTECH Corporation Full time

    DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...

  • Senior Regulatory Affairs Specialist

    2 months ago

    Miami Lakes, United States DemeTECH Corporation Full time

    DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Miami Lakes, United States DemeTECH Corporation Full time

    DemeTECH is seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Miami, United States ClinChoice Full time

    Position: Senior Regulatory Affairs SpecialistEmployment type: 1 year Contract/ PermanentLocation: Jacksonville, FL or Irvine CA - 2 days per week - REMOTE FOR THE RIGHT CANDIDATEClinChoice is a global CRO that offers high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical...

  • Sr Regulatory Affairs Specialist

    2 months ago

    Miami Lakes, United States DemeTECH Corp Full time

    Job DescriptionJob DescriptionWe are seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory...

  • Sr Regulatory Affairs Specialist

    1 week ago

    Miami Lakes, United States DemeTECH Corp Full time

    Job DescriptionJob DescriptionWe are seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory...

  • Sr Regulatory Affairs Specialist

    3 weeks ago

    Miami Lakes, United States DemeTECH Corp Full time

    Job DescriptionJob DescriptionWe are seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory...

  • Director / Senior Director, Business & Legal Affairs

    4 weeks ago

    Miami, United States NBC Universal Full time

    Company Description We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our theme parks and consumer experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, MSNBC, CNBC, NBC Sports, Telemundo, NBC Local Stations, Bravo, USA Network, and...

  • Director / Senior Director, Business & Legal Affairs

    3 weeks ago

    Miami, United States NBC Universal Full time

    Company Description We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring to life through our theme parks and consumer experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, MSNBC, CNBC, NBC Sports, Telemundo, NBC Local Stations, Bravo, USA Network, and...

  • Public Affairs Specialist

    4 weeks ago

    Miami, United States Veterans Health Administration Full time

    ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** Duties include, but may not be limited to the following: Functions as the senior public affairs specialist who is responsible for designing, planning, executing, and evaluating the public affairs program for VHA and the...

  • Public Affairs Specialist

    3 weeks ago

    Miami, United States Veterans Health Administration Full time

    ***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** Duties include, but may not be limited to the following: Functions as the senior public affairs specialist who is responsible for designing, planning, executing, and evaluating the public affairs program for VHA and the...

  • Public Affairs Specialist

    4 weeks ago

    Miami, Florida, United States Veterans Health Administration Full time

    THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATIONDuties include, but may not be limited to the following:Functions as the senior public affairs specialist who is responsible for designing, planning, executing, and evaluating the public affairs program for VHA and the Medical...

  • Public Affairs Specialist

    3 weeks ago

    Miami, Florida, United States Veterans Health Administration Full time

    THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATIONDuties include, but may not be limited to the following:Functions as the senior public affairs specialist who is responsible for designing, planning, executing, and evaluating the public affairs program for VHA and the Medical...

  • Legal Affairs Counsel

    2 weeks ago

    Miami, United States Rimas Entertainment LLC Full time

    **JOB DETAILS** **Title** Legal Affairs Counsel**Classification** Exempt**Department** Legal**Reports to** Director of Legal Affairs**YOU ARE ACCOUNTABLE** The Legal Affairs Counsel is responsible for drafting, negotiating, and finalizing client-label deals. Under the supervision of the Director of Legal Affairs, responsibilities are tailored to the...

  • AVP, Global Public Affairs

    1 month ago

    Miami, United States Royal Caribbean Group Full time

    ABOUT US Royal Caribbean Group comprises five distinctive brands that share a vision anchored in excellence. We have a common passion for creative thinking, innovative engineering and outstanding guest service that drives continuous improvement in everything we do. The entire Royal Caribbean family is committed to the legacy of hospitality and culture of...

  • Regulatory Affairs

    1 month ago

    Miami, United States Adistec Full time

    Job DescriptionJob DescriptionSalary: DOEJob Summary:Regulatory Affairs & Contract Management Manager will oversee the Compliance & Contracts while running and enhancing a companywide compliance program ensuring compliance of Business Practices. The Compliance & Contracts manager will drive complex compliance projects and lead cross-functional team in...

  • Regulatory Affairs

    4 weeks ago

    Miami, United States Adistec Full time

    Job DescriptionJob DescriptionSalary: DOEJob Summary:Regulatory Affairs & Contract Management Manager will oversee the Compliance & Contracts while running and enhancing a companywide compliance program ensuring compliance of Business Practices. The Compliance & Contracts manager will drive complex compliance projects and lead cross-functional team in...

  • Regulatory Affairs

    3 weeks ago

    Miami, United States Adistec Full time

    Job DescriptionJob DescriptionSalary: DOEJob Summary:Regulatory Affairs & Contract Management Manager will oversee the Compliance & Contracts while running and enhancing a companywide compliance program ensuring compliance of Business Practices. The Compliance & Contracts manager will drive complex compliance projects and lead cross-functional team in...