-
Regulatory Affairs Coordinator
3 weeks ago
The Henry M. Jackson Foundation for the Advancement of Military Medicine Bethesda, United StatesOverview: · **Join the HJF Team** · This position will be in support of HJF's Home Office Office of Regulatory Affairs & Research Compliance and the Gynecological Cancer Center of Excellence (GYNCOE) Program. · The Henry M. Jackson Foundation for the Advancement of Military Medic ...
-
Government and Regulatory Affairs Law Clerk
3 weeks ago
GEICO Chevy Chase, United StatesGEICO's Government and Regulatory Affairs (GRA) team develops and executes the company's public policy, legislative and regulatory agenda across all 50 states, the District of Columbia, and the federal government. The GPA team focuses most of its lobbying efforts in state legisla ...
-
Regulatory Affairs Manager
2 days ago
JTI - Japan Tobacco International Washington, United StatesWe'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 ...
-
Regulatory Affairs Specialist Us
3 weeks ago
Clinglobal Group Washington, United States**Regulatory Affairs Specialist - United States of America** · Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. · We are currently looking for a** Regulatory Affairs Specialist** based in the United States of A ...
-
Science & Regulatory Affairs Coordinator
3 weeks ago
CropLife America & RISE Arlington, United States: · **CropLife America (CLA), a trade association located in the Washington, DC area, is seeking a full-time Science & Regulatory Affairs Coordinator.** The Science & Regulatory Affairs Coordinator provides support to the full team across the spectrum of the departments' activiti ...
-
Public Policy and Regulatory Affairs
2 weeks ago
Cohere Washington, United States**Who are we?** · - Our mission is to scale intelligence to serve humanity. We're training and deploying frontier models for developers and enterprises who are building AI systems to power magical experiences like content generation, semantic search, RAG, and agents. We believe t ...
-
Regulatory and Government Affairs Manager
1 week ago
Rinnai America Corp Washington, United States**Creating A Healthier Way of Living** · Rinnai America Corporation is the leader in tankless water heating, a technology that is growing rapidly as businesses and homes "yank the tank" and convert to an efficient, endless supply of hot water and the only tankless water heating m ...
-
manager, regulatory affairs
1 week ago
Technical Resources International Bethesda, United StatesJob 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 multi ...
-
manager, regulatory affairs
5 days ago
Technical Resources International Bethesda, United StatesJob 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 multi ...
-
Director of Regulatory Affairs
2 weeks ago
Johns Hopkins Ambulatory Surgery Centers Bethesda, United StatesJob Summary · The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. Th ...
-
Director of Regulatory Affairs
4 weeks ago
Johns Hopkins HealthCare Bethesda, United StatesJob Summary · The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. T ...
-
Director of Regulatory Affairs
2 weeks ago
Johns Hopkins Medicine Bethesda, United States Full timeJob Summary · The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. Th ...
-
Senior Director of Regulatory Affairs
1 week ago
Precision for Medicine Bethesda, United StatesAre you looking for an opportunity where you can use your expertise to providestrategic, technical, and regulatory guidance for clinical development and drugdevelopment life cycles? A role where you can lead regulatory consultingservices and maintain technical knowledge in produc ...
-
A-Gas Americas Washington, United States**Vice President, Regulatory** · **About A-Gas** · **Who We Are** · A-Gas is committed to protecting the environment by effectively managing the lifecycle of refrigerants to build a sustainable future. Backed by private investors, TPG Rise Climate and KKR, A-Gas is leading the in ...
-
Associate Director, Cmc Regulatory Affairs
3 weeks ago
AstraZeneca Gaithersburg, United StatesThe role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and sophisticated product ranges from the development phase through to global launch and post-approval lifecycle management. Role holder w ...
-
Regulatory Affairs Manager
3 weeks ago
The Aluminum Association Arlington, United States Part timeRegulatory Affairs Manager – THE ALUMINUM ASSOCIATION, INC. · The Aluminum Association (TAA), based in Arlington, VA is searching for a Regulatory Affairs Manager. Established in 1933, TAA is the trade association for the North American aluminum industry and has a $10M budget. Th ...
-
Director, Regulatory Affairs
3 weeks ago
American Pharmacists Association Washington, United States Full timeDirector, Regulatory Affairs · Washington, D.C. · The American Pharmacists Association is the largest association representing pharmacists in all practice settings in the United States and is the only organization advancing the entire pharmacy profession. · Our expert staff, a ...
-
Regulatory Affairs Intern
1 week ago
MFA Washington, United StatesPosition Title: Regulatory Affairs Intern · Location: Washington, DC (Hybrid) · Reports to: Vice President, Senior Counsel, Regulatory Affairs · Accepting applications for Fall 2024 (Sept.17 - Nov. 26) · Company Background: · MFA, based in Washington, DC, New York, Brussels, and ...
-
Regulatory Affairs Specialist
1 week ago
CM Medical Recruitment Washington, United StatesCM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. · In this critical role, you will be responsible for developing and executing regulatory strategies to drive the successful commercialization of products across gl ...
-
Head of Regulatory Affairs
3 weeks ago
Block Washington, United StatesBlock 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 guidanc ...
Senior Director of Regulatory Affairs - Bethesda, United States - Precision for Medicine
Description
Senior Director of Regulatory Affairs - Remoteat Precision Medicine Group (View all jobs)
Frederick, MD, USA
Are you looking for an opportunity where you can use your expertise to provide strategic, technical, and regulatory guidance for clinical development and drug development life cycles? A role where you can lead regulatory consulting services and maintain technical knowledge in product development and international regulatory affairs? If so, we're hiring a Senior Director of Regulatory Affairs
About You:
You have 12+ years or more relevant regulatory affairs experience.
You possess a comprehensive understanding of financial management.
You have expertise in all aspects of the drug development process inclusive of regulatory milestones and clinical trials methodology, including a working knowledge of protocols and indications being studied.
You have specialized knowledge of regulatory activities including but not limited to submissions to regulatory authorities, including INDs/CTAs andamendments, ODDs, and PIPs.
You can understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
You are experienced in pharmaceutical product development and marketing authorizations (MAA/CTAs/INDS/NDA and or BLA/sBLA) experience in filings in an eCTD format.
You are eager to develop, coach, and mentor regulatory team members, ensuring the sharing of best practices across the team.
About the Role:
As a Senior Director of Regulatory Affairs, you are responsible for the provision of high-quality regulatory technical advice and development strategies for clients across a wide range of therapeutic indications and will provide regulatory strategy and leadership for all North America and/or International (inc. European) regulatory submissions.
You will lead and support teams and efforts around major filing activities and Health Authority interactions, and will provide regulatory support to other departments, project teams, and committees.
In this leadership role, you will support the further development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.
Required:
Post Graduate Degree, bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline
Experience in functional management including experience in delegating while fostering cohesive team dynamics
Computer literacy in MS Office/ Office 365
Availability for domestic and international travel including overnight stays
Who We Are
Precision for Medicine is the first global, precision-medicine, clinical research organization.
Purpose-built to shift the development curve for life sciences clients, we incorporate laboratory expertise, clinical trial excellence, and advanced data sciences at every stage.
Known as Precision Convergence, this integrated approach enables us to deliver critical insights into patient biology from early development through approval.
The result:
More predictable trial outcomes. Accelerated clinical development. New life-changing treatments for the patients around the globe.
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
skill sets, experience and training, licensure and certifications, and other business and organizational needs.
The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.
At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.
This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range$150,800 - $226,200 USD
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
