Current jobs related to Director, US Regulatory Policy and Regulatory Intelligence - Bethesda, Maryland - Moderna, Inc.
-
Regulatory Strategy Director
3 weeks ago
Bethesda, Maryland, United States Moderna Full timeAbout the RoleModerna is seeking a seasoned Regulatory Strategy Director to join our Global Regulatory Strategy, Infectious Diseases team. As a key member of our team, you will be responsible for developing and executing regulatory plans for our COVID-19 franchise programs in the US market.Key ResponsibilitiesStrategic Leadership: Collaborate with global...
-
Regulatory Strategy Director
3 weeks ago
Bethesda, Maryland, United States Moderna Full timeAbout the RoleModerna is seeking a seasoned Regulatory Strategy Director to join our Global Regulatory Strategy, Infectious Diseases team. As a key member of our team, you will be responsible for developing and executing regulatory plans for our COVID-19 franchise programs in the US market.Key ResponsibilitiesStrategic Leadership: Collaborate with global...
-
Regulatory Strategy Director
3 weeks ago
Bethesda, Maryland, United States Moderna Full timeAbout the RoleModerna, Inc. is seeking a seasoned professional to lead Regulatory Strategy for the COVID-19 franchise. This role requires a forward-thinking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for and licensure maintenance of messenger RNA COVID-19 vaccines.Key...
-
Regulatory Strategy Director
2 weeks ago
Bethesda, Maryland, United States Moderna Full timeAbout the RoleModerna, Inc. is seeking a seasoned professional to lead Regulatory Strategy for the COVID-19 franchise. This role requires a forward-thinking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for and licensure maintenance of messenger RNA COVID-19 vaccines.Key...
-
Regulatory Affairs Specialist
2 weeks ago
Bethesda, Maryland, United States Beacon Hill Life Sciences - Boston Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Beacon Hill Life Sciences - Boston. As a key member of our team, you will be responsible for preparing and submitting regulatory documents to various authorities, ensuring compliance with relevant regulations and guidelines.Key ResponsibilitiesRegulatory Document...
-
Intelligence Expert
2 weeks ago
Bethesda, Maryland, United States Office of the Director of National Intelligence Full timeJob SummaryThe Office of the Director of National Intelligence is seeking a highly qualified Counterproliferation Faculty member to join our team. As a key member of our faculty, you will be responsible for teaching courses in counterproliferation and core intelligence at the National Intelligence University.Key ResponsibilitiesTeach courses in...
-
Regulatory Strategy Manager
2 weeks ago
Bethesda, Maryland, United States Moderna Therapeutics Full timeAbout the RoleModerna Therapeutics is seeking a highly skilled Regulatory Strategy Manager to join our team in Cambridge, Massachusetts. As a key member of our Clinical Development team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with relevant regulations.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Affairs Coordinator
3 weeks ago
Bethesda, Maryland, United States Technical Resources International Full timeRegulatory Operations AssociateWe are looking for a meticulous Regulatory Operations Associate to become a part of our committed team at Technical Resources International. If you have a strong interest in regulatory affairs and hold a Bachelor's Degree, this role may be an excellent fit for you.Key Responsibilities:Preparation and organization of...
-
Regulatory Affairs Specialist
2 weeks ago
Bethesda, Maryland, United States The Geneva Foundation Full timeAbout the PositionThe Regulatory Affairs Coordinator plays a critical role in maintaining regulatory documents related to research, serving as the principal administration regulatory liaison for projects, developing and maintaining recordkeeping systems and procedures, supervising and preparing documents which support research projects, submitting and...
-
Regulatory Compliance Manager
2 weeks ago
Bethesda, Maryland, United States HR Retail Full timeRegulatory Affairs Manager - (MGRRA_HR_RETAIL) Share this job as a link in your status update to LinkedIn. Position Overview The Regulatory Affairs Manager is responsible for overseeing the regulatory team to ensure the successful management of various drug and biologic applications, including Investigational New Drug Applications (INDs), Biologics License...
-
Regulatory Compliance Manager
3 weeks ago
Bethesda, Maryland, United States HR Retail Full timeRegulatory Affairs Manager - (MGRRA_HR_RETAIL) Share this job as a link in your status update to LinkedIn. Position OverviewThe Regulatory Affairs Manager is responsible for overseeing the regulatory team to ensure the effective management of various drug and biologic applications. This role is critical in maintaining compliance with Good Clinical Practices...
-
Regulatory Compliance Manager
2 weeks ago
Bethesda, Maryland, United States HR Retail Full timeRegulatory Affairs Manager - (MGRRA_HR_RETAIL) Share this job as a link in your status update to LinkedIn. Position OverviewThe Regulatory Affairs Manager will oversee the regulatory team responsible for managing the lifecycle of various drug and biologic applications, ensuring adherence to all relevant regulations and...
-
Regulatory Policy Specialist
3 weeks ago
Bethesda, Maryland, United States PriceSenz Full timeJob OverviewThe role involves creating deliverables and documentation related to case management, which includes drafting correspondence, conducting research, analyzing, and evaluating data for responses to information requests.Minimum Education: Bachelor's DegreeKey Skills:Policy AnalysisTechnical WritingKey ResponsibilitiesThis position requires providing...
-
Regulatory Policy Specialist
3 weeks ago
Bethesda, Maryland, United States PriceSenz Full timeJob OverviewThe role involves generating various deliverables and documentation related to case management, including correspondence, conducting research, and analyzing data for information requests.Minimum Education: Bachelor's DegreeLocation: RemoteKey Skills:Policy AnalysisTechnical WritingKey ResponsibilitiesOffer specialized knowledge necessary for the...
-
Regulatory Affairs Specialist
3 days ago
Bethesda, Maryland, United States Technical Resources International Full timeJob Title: Regulatory SpecialistAt Technical Resources International, we are seeking a highly skilled Regulatory Specialist to join our team.Job SummaryWe are looking for a detail-oriented and organized individual to prepare, distribute, and track regulatory submissions, including INDs, BLAs, NDAs, and IDEs, ensuring compliance with GCPs/ICH and FDA...
-
Regulatory Health Expert
2 weeks ago
Bethesda, Maryland, United States Booz Allen Hamilton Full timeJob SummaryWe are seeking a highly skilled Regulatory Health Consultant to join our team at Booz Allen Hamilton. As a Regulatory Health Consultant, you will play a critical role in supporting the regulatory health portfolio on projects, including medical device and drug regulation, organizational excellence, strategic planning, regulatory science, program...
-
Bethesda, Maryland, United States Office of the Director of National Intelligence Full timeJob SummaryWe are seeking a highly skilled and experienced professional to serve as the Deputy Assistant Director of the Supply Chain & Cyber Directorate within the Office of the Director of National Intelligence. As a key member of our team, you will play a critical role in leading the implementation of strategic objectives and overseeing processes and...
-
Bethesda, Maryland, United States Office of the Director of National Intelligence Full timeJob SummaryThe Office of the Director of National Intelligence is seeking a highly skilled and experienced professional to serve as the Deputy Assistant Director for the Supply Chain and Cyber Directorate. This is a critical leadership position that requires a strong understanding of supply chain and cyber security principles, as well as excellent...
-
Senior Manager of Regulatory Affairs
2 weeks ago
Bethesda, Maryland, United States Moderna Therapeutics Full timeAbout the RoleModerna Therapeutics is seeking a highly skilled Regulatory Strategy Manager to join our team in Cambridge, Massachusetts. As a key member of our Clinical Development team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with relevant regulations.Key ResponsibilitiesDevelop and implement regulatory...
-
Regulatory Health Expert
3 days ago
Bethesda, Maryland, United States Booz Allen Hamilton Full timeJob SummaryWe are seeking a highly skilled Regulatory Health Consultant to join our team at Booz Allen Hamilton. As a key member of our regulatory health portfolio, you will support projects related to medical device and drug regulation, organizational excellence, strategic planning, regulatory science, program evaluation, and project management.Key...
Director, US Regulatory Policy and Regulatory Intelligence
4 months ago
The Role:
The US Regulatory Policy and Regulatory Intelligence Lead will be a strong subject matter expert in regulatory processes, laws, and regulations, with a strong understanding of how regulatory policy is shaped and developed in the US. This role will manage a highly collaborative function that addresses global policy intelligence gathering, analysis of changes in the regulatory environment, development of policy positions, and creation and execution of advocacy strategies to achieve policy goals, working collaboratively with both internal and external stakeholders to influence the policy environment set by the US Food and Drug Administration (FDA) and global Health Agencies. This individual will work closely with subject matter experts within Moderna to shape policies around the mRNA platform, assess the impact of regulatory policy on the companys products and goals, ensure unified US Regulatory Strategies across the portfolio.
Here's What Youll Do:
Defining and delivering a regulatory policy plan for the US that addresses current and future business needs, that is co-designed with Global Regulatory Sciences, Safety and Pharmacovigilance, Clinical Development and the Quality leadership and in partnership with our companys policy teams at the global, regional and country levels; Propose and respond to draft legislation, regulations, guidelines and policiesat the US level, as well as plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters in the US. Represent effectively Modernas position in the US and serve as the company representative internally and externally on key US policy topics to appropriately shape the regulatory environment with US FDA (e.g. interact with the FDA and engage in proactive policy activities policy topics, such as real world data, digital health, rare diseases, pediatrics, diversity in clinical trials, patient focused drug development, PDUFA) as well as engage with patient advocacy organizations, medical societies and key industry stakeholder such as DIA, BIO, etc. Manage on-site activities for select meetings with FDA and other health authorities (e.g., regulatory milestone meetings, management meet and greets, ad hoc policy-focused meetings) as assigned for specific projects. Providing insights and advocate for positionson critical regulatory issues and trends to Research and Development business partners and to contribute to a broader policy platform; and Build our companys share of voice and influence extramural to support the enterprise policy agenda through engagement in trade associations and representation for industry initiatives. Oversee and manage regulatory Intelligence resources and databases as well as access to them, and provide focused regulatory insights to the GRS organization and other stakeholders. Heres What Youll Bring to the Table: Bachelors Degree is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a Masters or Doctorate degree in science, health care, public health, health policy, or law; Doctorate degree and at least 10 years of experience with FDA, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR Masters degree and at least 10 years of experience with FDA, either directory (working within a health authority) or indirectly (closely interacting with health authority) OR Bachelors degree and at least 15 years of experience with FDA, either directly (working within a health authority) or indirectly (closely interacting with health authority); Proven capability in acting as a credible, influential and respected spokesperson able to convey complex messages, trends & insights; Deep understanding of the US regulatory environment, the Food, Drug and Cosmetic Act and latest regulations and guidances with sound knowledge of intelligence tools and methods; preference will be given to candidates with experience supporting vaccines and infectious disease products, and experience across a number of disciplines including Pharmacovigilance, Quality, and Clinical Development; Strong relationship management and interpersonal skills with superb written and oral and communication skills; Proven success at stakeholder engagement across organizational levels and boundaries with ability to manage highly complex situations and engender trust when dealing with sensitive issues; Ability to fully demonstrate our company leadership principles, driving results and building talent; Ability to thrive in a cross-functional team environment with a global mindset; Ability to travel internationally; Excellent command of English (written and spoken). Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)#LI-TR1
-
