Regulatory Affairs Specialist Project Lead

3 weeks ago


Washington, United States Cynet Systems Full time
Job Description:

Responsibilities:
  • Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory strategy or product portfolio.
  • Provide relevant ad hoc regulatory intelligence to internal stakeholders.
  • Effectively communicate impact and bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on products and goals.
  • Coordinate and lead internal teams to develop responses and comments on draft legislation, regulations, guidelines and regulatory policies issues.
  • Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on position.
  • Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
  • Lead proactive advocacy efforts for priority regulatory policy areas.
  • Consult with internal experts and leadership to identify priority issues.
  • In collaboration with internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies.
Education, Experience and Skill Requirement:
  • Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred
  • Minimum 3 years in Regulatory Affairs.
  • Established regulatory experience.
  • Effective collaboration.
  • Familiarity and understanding of the drug/biologic development and commercialization process.
  • Excellent written, oral, and presentation communication skills Excellent command of English (written and spoken).
  • Superior time management and organizational skills.
  • bility to lead multiple complex initiatives (short, mid and long-term).
  • Self-motivated, prone to action and results oriented.
  • Provides an engaging and motivating work environment.


  • Washington, United States Integrated Resources Full time

    Job Title: Regulatory Affairs Specialist Project Lead I  Location: Washington D.C., DC (Fully Remote)  Duration: 06 months +   Part-Time Role- (Mon - Fri 9 AM - 1 PM EST)    Job Description:  Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for different time zones) No issue with dual part-time employment simultaneously, however,...


  • Washington, United States Edison Electric Institute Full time

    **Overview** The Edison Electric Institute (EEI) is seeking a talented and committed intern to join the State Regulatory Affairs team this summer. This role provides the opportunity to learn about and support the portfolio of projects and programs within our state regulatory affairs team. The dates of this internship are mid-May through mid-August and...


  • Washington, United States Tempus Full time

    Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...


  • Washington, United States TechOp Solutions International Full time

    Location: Remote We are seeking an experienced Senior Public Affairs Specialist who is ready to step up and lead in the execution and strategic planning of our Public Affairs programs and activities. This role is perfect for professionals who have a deep understanding of Public Affairs initiatives and are looking to apply their skills in a more strategic and...


  • Washington, United States TechOp Solutions International Full time

    Job DescriptionJob DescriptionLocation: Remote We are seeking an experienced Senior Public Affairs Specialist who is ready to step up and lead in the execution and strategic planning of our Public Affairs programs and activities. This role is perfect for professionals who have a deep understanding of Public Affairs initiatives and are looking to apply their...


  • Washington, United States MFA Full time

    Position Title: Regulatory Affairs InternLocation: Washington, DC (Hybrid)Reports to: Vice President, Senior Counsel, Regulatory AffairsAccepting applications for Fall 2024 (Sept.17 - Nov. 26) Company Background:MFA, based in Washington, DC, New York, Brussels, and London, represents the global alternative asset management industry. MFA’s mission is to...


  • Port Washington, United States Drive Medical Full time

    Job DescriptionJob DescriptionWho is Drive DeVilbiss…Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold...


  • Port Washington, United States Drive Medical Full time

    Job DescriptionJob DescriptionWho is Drive DeVilbiss…Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold...


  • Washington, United States TechOp Solutions International Full time

    Job DescriptionJob DescriptionLocation: Remote We are looking for a motivated Public Affairs Specialist to enhance our team. This role is designed for individuals with solid background in public affairs, ready to take on more responsibility and contribute to complex projects. The ideal candidate will have a track record of public affairs initiatives and a...


  • Washington, United States TechOp Solutions International Inc Full time

    Description Location: Remote We are seeking an experienced Senior Public Affairs Specialist who is ready to step up and lead in the execution and strategic planning of our Public Affairs programs and activities. This role is perfect for professionals who have a deep understanding of Public Affairs initiatives and are looking to apply their skills in a more...

  • Global Affairs Lead

    3 days ago


    Washington, United States Hyundai Motor Group Full time

    Overview:We are seeking a Global Affairs Lead to join the Hyundai Motor Group Government Affairs team in Washington, D.C. The Global Affairs Lead will advance the Government Affairs function for Hyundai Motor Group (“the Group”), ensuring proactive engagement and effective advocacy with government entities and think tanks that allows the Group to foster...


  • Washington, United States TechOp Solutions International Inc Full time

    Description Location: Remote We are looking for a motivated Public Affairs Specialist to enhance our team. This role is designed for individuals with solid background in public affairs, ready to take on more responsibility and contribute to complex projects. The ideal candidate will have a track record of public affairs initiatives and a keen understanding...


  • Washington, United States Bureau of Engraving and Printing Full time

    Summary This position is located at Bureau of Engraving and Printing, within the External Affairs Division DCF. As a Supervisory Public Affairs Specialist, you will be responsible for planning, organizing, analyzing, implementing and evaluating broad public information and education programs, coordinating all public affairs activities, and managing...


  • Washington, United States Physicians Committee for Responsible Medicine Full time

    Job DescriptionJob DescriptionNonprofit advocacy organization dedicated to saving and improving human and animal lives through ethical and effective scientific research seeks a scientist with a master's or doctoral degree in toxicology, pharmacology, cell biology, or a related field and at least seven years of experience in a nongovernmental...


  • Washington, United States Peace Corps Full time

    The Public Affairs Specialist performs the following major duties: Public Affairs Program Planning and Evaluation Communications, Liaison and Information Dissemination Marketing, Publicity, Promotional and Instructional Matterials VIP Visit Coordination


  • Washington, Washington, D.C., United States Treasury, Departmental Offices Full time

    As a Public Affairs Specialist, you will:Develop and implement a public affairs and social media program evaluation plan, in order to evaluate the program's efficiency and effectiveness for public affairs and social media. Advise the Director of the OFR or his designee, and coordinates with the Treasury's Office of Legislative and Public Affairs Office on...


  • Washington, Washington, D.C., United States Peace Corps Full time

    The Public Affairs Specialist performs the following major duties:Public Affairs Program Planning and Evaluation Communications, Liaison and Information Dissemination Marketing, Publicity, Promotional and Instructional Matterials VIP Visit Coordination


  • Washington, United States Physicians Committee for Responsible Medicine Full time

    Job DescriptionJob DescriptionNonprofit advocacy organization dedicated to saving and improving human and animal lives through ethical and effective scientific research seeks a scientist with a master's or doctoral degree in toxicology, pharmacology, cell biology, or a related field and at least five years of experience in a nongovernmental organization,...


  • Washington, United States U.S. Army Military District of Washington Full time

    Summary About the Position: Serve as a Public Affairs Specialist in the Media Relations Division of the United States Army Military District of Washington, Directorate of Public Affairs, a United States Army major command headquartered at Fort Lesley J. McNair, Washington, DC.


  • Washington, United States Square Full time

    Block is one company built from many blocks, all united by the same purpose of economic empowerment. The blocks that form our foundational teams People, Finance, Counsel, Hardware, Information Security, Platform Infrastructure Engineering, and more provide support and guidance at the corporate level. They work across business groups and around the globe,...