Senior Regulatory Affairs jobs in District of Columbia
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SENIOR REGULATORY AFFAIRS ADVISOR
Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...
| Company | Cook Device Solutions |
|---|---|
| Address | Remote |
| Category | Retail |
| Salary | $100,000 - $125,000 a year |
| Job type | Full-time |
| Date Posted | 2 months ago See detail |
Senior Regulatory Affairs Advisor
Cook Device Solutions
Remote
$100,000 - $125,000 a year
Authors submissions and other regulatory documents to obtain approval to bring new or modified products to market, including but not limited to FDA 510(k) submissions and EU MDR Technical Files. Manages communications with regulat...
2 months ago seen See more...
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Senior Manager, Regulatory Affairs Vendor Governance
Biospace
California, United States
Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...
7 days ago seen See more...
- View all Biospace jobs - jobs in California State
Senior Data Analyst - Revenue and Regulatory New
Hard Rock Digital
Remote
$89.7K - $114K a year
Recognize and diagnose potential errors or data inconsistencies between multiple reports. Investigate any irregularities with the finance and data engineering teams. Translate internal and external reporting needs into SQL queries...
24 hours ago seen
Clinical Affairs Senior Manager Immunossays
Biomérieux
United States
A family-owned company, bioMrieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve publi...
2 days ago seen
Regulatory Affairs Senior Consultant
Medenvoy Global Bv
Remote
From $100,000 a year
Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...
a month ago seen See more...
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Senior Manager, Regulatory Affairs
Apellis Pharmaceuticals
Remote
$132K - $167K a year
Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications,...
a month ago seen See more...
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Senior Manager, Regulatory Affairs, CMC
Beigene
Remote
$133,400 - $178,400 a year
Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...
a month ago seen See more...
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Senior Manager, Global Product Strategy (Regulatory Affairs)
Pharming Group
United States
$125K - $158K a year
Assisting in the development of Global Product regulatory strategies. Developing regulatory timelines aligned to company strategic goals including key regulatory milestones and activities. Acting as regulatory representative on cr...
2 months ago seen See more...
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Regulatory Affairs Associate - North Chicago, United States - Validation Associates
Validation Associates
United States
As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership...
5 days ago seen
Senior Counsel, Regulatory & Legislative Affairs
The Clearing House
Remote
$135K - $171K a year
JD and Licensed attorney, preferably in NY or DC. 5-10 years experience working on payments-related matters in a law firm, bank, or regulatory agency, or on advocacy for the financial industry. Demonstrated ability to quickly gra...
a month ago seen See more...
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Sr. Specialist, Regulatory Affairs CMC
Biospace
United States
Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...
2 weeks ago seen See more...
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Associate Director, Regulatory Affairs Advertising and Promotion
Biospace
California, United States
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...
2 weeks ago seen See more...
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Regulatory Affairs Manager - Now Hiring
Abbott Laboratories
Texas, United States
$95000 - $190000 per year
Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...
2 weeks ago seen See more...
- View all Abbott Laboratories jobs - jobs in Texas State
Senior Director, Cellular Therapy Patient & Professional Relations, Public Affairs
Biospace
California, United States
Serve as a strategic business partner and advisor to Commercial and R&D teams, leveraging advocacy expertise, business acumen and interpersonal skills to bring the voice of the patient to Kite's planning and programming. Manage ke...
a week ago seen See more...
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Director, Digital Health Regulatory Affairs
Mcra
West Virginia, United States
Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...
3 weeks ago seen See more...
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Senior Director– Global Medical Affairs, Lilly Diabetes and Obesity
Biospace
Remote - Indiana, United States
Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implem...
3 weeks ago seen See more...
- View all Biospace jobs - jobs in Indiana State
Senior Attorney (Power, Transmission and Regulatory)
York Power Authority
United States
Under the general direction of an Assistant General Counsel, work directly with senior management to develop a deeper knowledge and understanding of NYPAs and its subsidiaries business operations to provide relevant legal advice...
3 weeks ago seen See more...
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Senior Economic Affairs Officer
United Nations Secretariat
United States
Empowering Others: Delegates responsibility, clarifies expectations, and gives staff autonomy in important areas of their work; encourages others to set challenging goals; holds others accountable for achieving results related t...
3 weeks ago seen See more...
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Senior Director - Analytical Regulatory Science
Biospace
California, United States
Drives and supervises team members to drive analytical control strategy development and justification in regulatory filings for projects throughout product lifecycle. Guides project teams on preparation of analytical filing conten...
3 weeks ago seen See more...
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Manager Regulatory Affairs
Philip Morris
Washington, United States
Were 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. Monitors & facilitates...
a month ago seen See more...
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Regulatory Affairs Manager
Freudenberg Group
Remote
$94.6K - $120K a year
Provide regulatory excellence to the organization and guide decision making Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and b...
a month ago seen See more...
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Principal Regulatory Affairs Specialist (medlance.co)
Medlance
Remote
$30 - $300 an hour
Lead regulatory strategy development for medical device projects. Manage submissions to regulatory bodies. Advise on regulatory requirements and changes. Collaborate with cross-functional teams for regulatory compliance. Extensive...
a month ago seen See more...
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Regulatory Affairs Specialist
Redbock- An Nes Fircroft Company
Remote
$70.9K - $89.8K a year
Prepare and maintain international submission dossiers. Prepare electronic pre-market and post-market regulatory submissions. Compile Technical Documentations for IVD medical devices. Monitor progress on project deliverables and p...
a month ago seen See more...
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Regulatory Affairs Specialist
Brs
Remote
$62.1K - $78.7K a year
Contractor shall have at least 5 years experience applying FDA research regulatory requirements within a research Regulatory Affairs program office. Work in preparing ones own research proposals and ones own submissions to an IR...
a month ago seen See more...
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Director, CMC Regulatory Affairs Biologics
Biospace
California, United States
Lead CMC regulatory strategy for a single or multiple products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of pro...
a month ago seen See more...
- View all Biospace jobs - jobs in California State
Associate Director, Regulatory Affairs - West Chester, PA
Teva Pharmaceuticals
United States
Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...
a month ago seen See more...
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Regulatory Affairs Specialist II
Bausch + Lomb
Remote
$65,000 - $95,000 a year
Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation p...
a month ago seen See more...
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Director, Regulatory Affairs Advisor & Liaison
Capital One
Virginia, United States
Enjoy working with banking regulators Closely follow digital and technological developments in banking and financial services Understand and appreciate technology and cyber security risk management Relish interacting with senior l...
a month ago seen See more...
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Regulatory Affairs Manager - Electrophysiology
Abbott Laboratories
Minnesota, United States
$95,000 - $190,000 a year
Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...
a month ago seen See more...
- View all Abbott Laboratories jobs - jobs in Minnesota State
Manager, Regulatory Affairs
Bausch + Lomb
Remote
$90,000 - $130,000 a year
BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. to analyze impact on Company produc...
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