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Regulatory Affairs Associate
Exelixis
-
Alameda, CA / King of Prussia, PA
/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t
Email Job
Posted 5 days ago
Management and Program Assistant (Office Automation) (6 Month Register)
Internal Revenue Service
-
Hartford, CT / New Haven, CT / Norwalk, CT / 57 more...
Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than
Email Job
Posted 15 days ago
Regulatory Affairs Compliance and Planning- Project Manager
Kyowa Kirin
-
Princeton, NJ
Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state of the art biotechnologies to discover and deliver novel medicines in four disease areas bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments c
Email Job
Posted 9 days ago
Regulatory Affairs Manager - Cosmetics (Remote)
Church & Dwight
-
Ewing Township, NJ
A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner
Email Job
Posted 6 days ago
Director, Regulatory Affairs
Jubilant Draxlmage Radiopharmacies Inc, dba Jubilant Radiopharma
-
Yardley, PA
As the Director of Regulatory Affairs, you will lead a talented team and drive regulatory strategies for our groundbreaking products, focusing on New Drug Applications (NDAs) and Biologic License Applications (BLAs). You will spearhead the preparation and submission of regulatory documents, ensuring compliance with stringent FDA regulations and facilitating productive eng
Email Job
Posted 12 days ago
Appeals Officer (Estate and Gift) 6 Month Register
Internal Revenue Service
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Anchorage, AK / Birmingham, AL / Phoenix, AZ / 74 more...
Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most
Email Job
Posted 9 days ago
GRC Compliance Specialist
Marcum
-
East Hanover, NJ / St. Louis, MO / Ellsworth, ME / 34 more...
The GRC Specialist is responsible for assessing, managing, and mitigating risks associated with third party vendors and service providers. Implement security best practices, policies, and controls through a repeatable process. This role involves conducting thorough security evaluations of potential and existing vendors, conducting regular security awareness trainings, and
Email Job
Posted 9 days ago
Director, Global Regulatory Affairs, Vaccines
GlaxoSmithKline
-
Rockville, MD / Collegeville, PA
Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 11 2024 Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a
Email Job
Posted 11 days ago
Senior Manager, Regulatory Information Management (Remote)
Jazz Pharmaceuticals
-
Philadelphia, PA
The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing well as other functions within Jazz, to manage training, documentation, user experience, and maintenance of the RIM system and integration with the other systems at Jazz Essential Functions Understand the business processes (across R&D and Manufacturing), regulatory a
Email Job
Posted 13 days ago
Senior Director, Regulatory Affairs, Advertising and Promotions
Marinus Pharmaceutical
-
Radnor, PA
PI238824058
Email Job
Posted 24 days ago
Director, Regulatory Affairs, Specialty
GlaxoSmithKline
-
Collegeville, PA
include Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategies in support of the project globally. Lead regulatory interactions and the review processes in local region. Ensuring appropriate interaction with regional commercial teams in local re
Email Job
Posted 8 days ago
Senior Regulatory Affairs Associate (CTA)
Parexel International Corporation
-
King of Prussia, PA
We are looking for a Senior Regulator y Affairs Associate to join our growing team in Romania. This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various European locati
Email Job
Posted 8 days ago
Director Regulatory Affairs, Vaccines
GlaxoSmithKline
-
Rockville, MD / Collegeville, PA
Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Feb 20 2024 Are you looking for a highly visible role where you can ensure the development and execution of appropriate strategies across all stages of the product life cycle consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP)? If so, this role could be an exciting op
Email Job
Posted 18 days ago
Regulatory Affairs Diagnostic Strategy Lead
Spark Therapeutics
-
Philadelphia, PA
Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of global regulatory strategy to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional con
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Posted Today
Associate Director, Regulatory Affairs - Athens, OH, San Diego, CA, or Remote
QuidelOrtho
-
Raritan, NJ / Athens, OH / San Diego, CA
Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory
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Posted 19 days ago
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