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Technical Resources International
Bethesda, MD, United States
Job Title MANAGER, REGULATORY AFFAIRS Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Applicatio
Job Source: Technical Resources InternationalJohns Hopkins Medicine
Bethesda, MD, United States
The Johns Hopkins Health System Corporation is a not-for-profit organization dedicated to providing the highest quality of care in the treatment and prevention of human illness. JHHS is an academically based health system consisting of: The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Johns Hopkins Howard County Medical Center, Sub
Job Source: Johns Hopkins MedicineTechnical Resources International
Bethesda, MD, United States
Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application
Job Source: Technical Resources InternationalJT International S.A.
Washington, DC, United States
We're JTI, Japan Tobacco International and we believe in freedom . We think that the possibilities are limitless when you're free to choose. In fact, we've spent the last 20 years innovating, creating new and better products for our consumers to choose from . It's how we've grown to be present in 130 countries. But our business isn't just busine
Job Source: JT International S.A.Amgen
Washington, DC, United States
**HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading
Job Source: AmgenHR Retail
Bethesda, MD, United States
Regulatory Affairs Manager - (MGRRA_COMPANY_1) Share this job as a link in your status update to LinkedIn. Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multip
Job Source: HR RetailPhilip Morris USA
Washington, DC, United States
Manager Regulatory Affairs Be a part of a revolutionary change At PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. We can now provide legal a
Job Source: Philip Morris USAJTI Inc
Washington, DC, United States
We're JTI, Japan Tobacco International and we believe in freedom . We think that the possibilities are limitless when you're free to choose. In fact, we've spent the last 20 years innovating, creating new and better products for our consumers to choose from . It's how we've grown to be present in 130 countries. But our business isn't just busine
Job Source: JTI IncWashington, DC, United States
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Professional area: Corporate Affairs & Communications
Contract type: Permanent
Professional level: Experienced
Location: Washington, DC, US, 00000
We’re JTI, Japan Tobacco International and we believe in freedom . We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our consumers to choose from . It’s how we’ve grown to be present in 130 countries.
But our business isn’t just business. Our business is our people. Their talent. Their potential. We believe when they’re free to be themselves, grow, travel and develop, amazing things can happen for our business .
That’s why our employees, from around the world, choose to be a part of JTI. It is why 80% of employees feel happy working at JTI. And why we’ve been awarded Global Top Employer status, ten years running .
So when you’re ready to choose a career you’ll love, in a company you’ll love, feel free to #JoinTheIdea.
This position is responsible for managing JTI USA's regulatory monitoring, strategic engagement and communication program, to ensure an efficient and consistent approach to collecting, evaluating and communicating tobacco regulation developments in the USA. More specifically, this position is responsible for responding to regulatory proposals, engaging with regulators, and supporting JTI USA in regulatory submissions. In addition, this position is responsible for regulatory trends analysis to provide management with relevant and actionable information to address federal regulatory issues.
What you will do Responsible for developing and managing the US regulatory processes, tools and resources with a focus on current and future FDA regulations;
Draft regulatory proposal responses and coordinate with relevant functions to submit comprehensive comments. Represent company in key forums by presenting company positions on complex regulation;
Further expand our relationships with key regulators - Identify opportunities for engaging with regulators on regulatory proposals, regulatory submissions, or other relevant issues at hand. Support government affairs team with complex regulatory advocacy to relevant legislative committees. Continue building on successful informational material that can be presented clearly and concisely to policymakers;
Coordinate and manage contacts with consultants and advisors on regulatory issues such as interpretation of regulations, regulatory submissions and other relevant regulatory issues;
Monitor and analyze regulatory trends. Develop internal reports and presentations regarding status of regulatory issues for management;
Manage various tasks and projects as they arise and upon manager’s request.
Who We Are Looking For A dynamic, passionate, and result-oriented person, with:
Minimum BA with specialization in regulatory science, communication, law, public relations, or relevant work experience;
Management of regulatory policy issues. 5+ years work experience in regulatory affairs required. Candidates with experience in the tobacco, pharma, government agencies or other regulated industry preferred;
What We Offer In JTI USA, we are proud to be recognized as Top Employer and awarded the Global Equality Standards certificate as we continue our dedication to equal pay and equal opportunities.
Our culture is what makes JTI USA a fun and exciting environment to work in. We value integrity, trust, empowerment, and freedom - freedom of choice, freedom of thought, freedom of expression, and freedom to be yourself.
We ask for accountability, ownership, results, and collaboration.
And we care for our people's well-being - In addition to the salary, you might want to enjoy the following:
Annual Performance based Bonus
Employee Stock Purchase Plan
Personal Development
Medical/ Dental & Vision Plan for employee & family members.
Life insurance
Matching 401(K)
Paid Time Off (PTO)
Paid Family Leave of 20 Weeks
Short-Term & Long-Term Disability
Education/ Tuition Assistance
Flexible Dress Code
Hybrid Work Setup
Office Parties
Employee Assistance Program - counseling, for employees & family members.
In addition to other perks & benefits (i.e. fitness/ wellbeing activities, employee discounts, service awards, recognition program, etc.)
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Email Alert for Regulatory Affairs Manager jobs in Washington, DC, United States
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