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DIRECTOR, REGULATORY AFFAIRS, ONCOLOGY - JOB ID: 1311

Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance. Life Insurance (Basic, Voluntary & AD&D)....

CompanyAscendis Pharma
AddressPalo Alto, CA
CategoryInformation Technology
Job typeFull-Time
Date Posted 4 weeks ago See detail

Director, Regulatory Affairs, Oncology - Job ID: 1311

Ascendis Pharma

Palo Alto, CA

Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance. Life Insurance (Basic, Voluntary & AD&D)....

Director, Clinical Regulatory Affairs

Cymabay Therapeutics

Newark, CA

Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products. Develop global regulatory plans to facilitate the progress of programs in all phases of development. Identify risk mitigatio...

Certification and Licensing Coordinator, Regulatory Affairs, Full time, Days

Pih Health

Los Angeles, CA

Effective written/oral communication, and presentation skills. Problem-solving skills. Strong knowledge of performance improvement tools and techniques. Proficient computer literacy. California RN License. Bachelors Degree in hea...

Specialist - Regulatory Affairs

Biospace

Plainsboro, NJ

Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...

Director Regulatory Affairs *Remote*

Providence

Beaverton, OR

Be responsible for managing and developing a team tasked with performing regulatory consulting and regulatory product lifecycle support for all Providence Health Plan and Providence Health Assurance business activity and strategic...

Director, Regulatory Affairs Strategy, Hematology

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

Director, Regulatory Affairs Strategy, Hematology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

Head/ Sr Director of Global Regulatory Affairs

Predicine, Inc

Hayward, CA

Responsible for setting strategy and leading the Predicine Global Regulatory Affairs organization. Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnos...

Director Regulatory Affairs

Nikang Therapeutics Inc

Wilmington, DE

Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...

Vice President Regulatory Affairs, Obesity

Biospace

Thousand Oaks, CA

Develops the vision of the Regulatory Therapeutic Area for Obesity and Obesity Related Conditions (ORCs) and drives its execution, ensuring the globalization of strategy and process. Represents the Regulatory Affairs Therapeutic A...

Regulatory Affairs Specialist I

Fresenius Kabi Ag

Lake Zurich, IL

Collaborate with local and international colleagues to generate high quality submissions to obtain drug and/or medical device approvals in target markets. Gather design and development information on products from cross-functional...

Regulatory Affairs Specialist

Argen Corporation

San Diego, CA

Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. Our Awesome Benefits!Working for a growing innovative compa...

Banking Regulatory Affairs, Assistant Vice President

Pix11

New York, NY

Background in regulatory relations and knowledge of heightened regulatory environment. Manage the standing MIS regulatory request process and submit all requested MIS to regulators. Provide support to RAO Team Leaders on regulator...

Director Regulatory Reporting - Sr. Group Manager

Citigroup

Lorida, FL

The GRR Group is a high-profile function, providing financial information to the regulators including the Federal Reserve Bank (FRB) and Office of the Comptroller of the Currency (OCC). This individual will have an opportunity to...

Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience

Biospace

Remote

As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and...

Regulatory Risk & Oversight Manager

Northern Trust

Chicago, IL

Unspecified

Responsible for supporting the definition and leading the execution against the identified pillars of the Program as a named Program Lead. Over time identifying and managing a small global team who will enable execution of the new...

Regulatory Risk Managment Specialist

Northern Trust

Boston, MA

Unspecified

Regulatory Framework & Governance. Regulatory Change Oversight. Regulatory Risk Management. Regulatory Strategy & Sustainability. Actively support the embeddedness of the regulatory change framework and relevant regulatory account...

Managing Counsel, Educational Affairs & Governa...

A Public University In Oakland, Ca

Oakland, CA

Manages Ogc Attorneys to Achieve High Quality Work Products from Each Individual and Meet Departmental Service Expectations. Provides an Environment of Individual Growth and Career Development, Recognizing and Utilizing Skills of...

Regulatory & Management System Manager

The Coca-Cola Company

Apopka, FL

Interpret and communicate TCCC requirements and external standards to ensure continuous improvement of the Integrated Management System. Manage third-party audits, including TCCC Corporate, and address any identified compliance ga...

Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)

Laboratoire Guerbet

Princeton, NJ

Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...

Director, Precision Medicine and Digital Health - Global Regulatory Affairs

Takeda Pharmaceuticals

Boise, ID

You will also establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests, and Digital tools to ensure goals/objectives are met. + Und...

Director, Regulatory Affairs - Pharmaceuticals

Stryker

Mahwah, NJ

Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...

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...

Senior Associate of Regulatory Affairs, CMC

Meitheal Pharmaceuticals Inc

Chicago, IL

Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...

Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance

Ferring Pharmaceuticals

Parsippany, NJ

Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...

VP, Legal - Regulatory Affairs

A Biotechnology Company

Washington, DC

Working directly with clients, provide strategic and practical legal counsel on a wide variety of drug and medical device development legal and regulatory issues. As a strategic partner, work to identify and advise on business and...

2024 Summer Intern -Regulatory Affairs

Colgate-Palmolive

Topeka, KS

Must be current student, in good academic standing, post-second year or higher, and seeking a degree in Grain or Feed Science, Animal or Veterinary Science, Animal Nutrition, Biology, or Business Analytics/ Information Systems. M...

Public Affairs Manager, Security Engineering

Meta

Remote - San Francisco, CA

Build and execute proactive communications programs for press, policy makers, and other groups that highlight the work Meta does to protect our community and company. Manage in-bound press inquiries on a range of time-sensitive is...

Sr. Regulatory Affairs Specialist - Cardiac Diagnostics CDx

Boston Scientific

Hills, MN

Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices. Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, inc...