Regulatory Affair Lead jobs

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REGULATORY LEAD HQ AB

Strong verbal and written communication skills to convey complex ideas clearly and effectively. . Proficiency with MS Office software suite and data reporting. . Critical thinking skills to gather data and make decisions independe...

CompanySimplot
AddressBoise, ID
CategoryInformation Technology
Date Posted just now See detail

Regulatory Lead HQ AB New

Simplot

Boise, ID

Strong verbal and written communication skills to convey complex ideas clearly and effectively. . Proficiency with MS Office software suite and data reporting. . Critical thinking skills to gather data and make decisions independe...

USA Regulatory Affairs Specialist Project Lead I Scientific

Adecco

Bridgewater, NJ

$ 88 - $ 89.22 / Hour

Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

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Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

Regulatory Affairs Manager Regional Regulatory Lead

Biospace

Washington, DC

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US. Provide content for and coordinate US regulatory documents and meetings in accordance with GRT s...

Manager, Global Regulatory Affairs CMC Submissions Management

Biospace

Lexington, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...

Director, Regulatory Affairs Vaccines CMC

Biospace

Boston, MA

Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed. Participate in...

Senior Manager, Regulatory Affairs - General Medicine

Biospace

Basking Ridge, NJ

Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...

Manager Regulatory Affairs

Teva Pharmaceuticals

Parsippany, NJ

Requires a Bachelors degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience. Must have 2 years of sterile/ parenteral dosage form experience...

Senior Regulatory Affairs Specialist

Johnson & Johnson

Danvers, MA

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Regulatory Affairs Manager

Amgen

Washington, DC

Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.. Develops the international regulatory strategy and contributes to global regulatory plans.. Support regulatory product compli...

Senior Manager CMC Regulatory Affairs

Biospace

Basking Ridge, NJ

Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...

Associate Director, Regulatory Affairs (Advertising and Promotion)

Bausch Health

Bridgewater, NJ

Provides regulatory review of Advertising and Promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of Advertising and Promotional material to meet internal timelines...

Director or Senior Director, Regulatory Affairs

Veranex, Inc.

San Jose, CA

$165,000 - $263,000 a year

Responsible for managing and prioritizing workload for regulatory staff. Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients,...

Regulatory Affairs Specialist III

Boston Scientific

Maple Grove, MN

Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE...

Senior Product Stewardship & Regulatory Affairs Specialist Job

Arkema

United, PA

Prepare and maintain commercial and R&D composition databases, SDSs and labels, packaging requirements, certificates of compliance (Kosher, FDA, RoHS etc.), product registrations and approvals (including FIFRA, NSF, UL, etc.), for...

Global Medical Affairs Lead, Uplizna

Amgen

Washington, DC

Serve as the Medical Affairs Representative on various global strategic teams.. Support the development of the integrated evidence generation plan for neuromyelitis optica spectrum disorder and other follow-on indications.. Captur...

Manager, Global Regulatory Affairs, Marketed Products - Now Hiring

Takeda Pharmaceutical

Bronx, NY

$186,000 per year

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and. I further attest that...

Global Medical Affairs Lead, Uplizna

Biospace

Washington, DC

Serve as the Medical Affairs Representative on various global strategic teams. Support the development of the integrated evidence generation plan for neuromyelitis optica spectrum disorder and other follow-on indications. Capture...

VP/TA Head, General Medicine - Global Regulatory Affairs

Merck

Rahway, NJ

Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...

Regulatory Affairs Intern (Onsite)-Summer-Fall 2024

Becton Dickinson

Covington, GA

Assist with product submissions and regulatory assessments. Ensure compliance with all relevant regulatory requirements. Improve departmental procedures and processes. Assist with regulatory assessments for design change and non-d...

Manager, Global Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

$133,200.00 to $223,200.00 per year

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

Director - Global Regulatory Lead

Biospace

Plainsboro, NJ

Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulato...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

Director, Global Medical Affairs Lead

Biospace

Waltham, MA

Serve as a medical subject matter expert on ASOs and other therapeutic modalities for our NMD programs. Serve as internal expert on medical literature / data associated with our NMD programs. Represent GMA on cross-functional team...

Head of Regulatory Affairs Policy & Regulatory Intelligence

Biospace

Thousand Oaks, CA

Lead teams of policy experts and subject matter experts to accomplish policy goals. Recruit and retain highly qualified and diverse professional policy and Regulatory Intelligence professionals, ensuring they are appropriately qua...

Regulatory Exam Lead, Vice President

State Street

Clifton, NJ

Not disclosed

Examination planning and supporting pre-examination readiness exercises, focusing on a risk discipline, i.e. Financial or Non-Financial risk. Reviewing Regulatory Exam requests and providing a review/evaluation of the quality, acc...

Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology

Astrazeneca

Boston, MA

Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...

Regulatory Affairs Director, Oncology

Astrazeneca

Waltham, MA

Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...

Manager, Global Regulatory Affairs CMC Submissions Management - Now Hiring

Takeda Pharmaceutical

New York, United States

$138,500 - $186,000 per year

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...