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Senior Director Regulatory Affair jobs

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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS STRATEGY - GENETIC MEDICINE

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...

CompanyBiospace
AddressNew York, NY
CategoryInformation Technology
Job typeFull time
Date Posted 4 weeks ago See detail

Associate Director, Regulatory Affairs Strategy - Genetic Medicine

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...

4 weeks ago seen See more...

Senior Director, Regulatory Information Management

Biospace

Waltham, MA

Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...

4 weeks ago seen See more...

Associate Director - Regulatory Affairs - AD Promo

Biospace

Princeton, NJ

Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...

a month ago seen See more...

Director Regulatory Affairs

Paysafe

Jacksonville, FL

Bachelor's degree; advanced degree preferred. Minimum of 8 years of experience in Regulatory Affairs, compliance, or legal roles within the financial services industry, with a focus on payments, fintech, or e-commerce. Strong unde...

a month ago seen See more...

Director Regulatory Affairs - Submission Management - West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Responsible to manage Product Submission Team and dossier timelines. Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management. Regularly reports to management on progr...

a month ago seen See more...

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)....

a month ago seen See more...

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...

a month ago seen See more...

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...

a month ago seen See more...

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...

a month ago seen See more...

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...

a month ago seen See more...

Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.

Johnson & Johnson

Santa Clara, CA

...

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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...

a month ago seen See more...

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...

a month ago seen See more...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

...

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Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

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Director, Regulatory Affairs

Biospace

San Diego, CA

Accountable for the development and implementation of the regulatory strategy for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively neg...

a month ago seen See more...

Associate Director, Regulatory Affairs

Biospace

San Rafael, CA

Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Cli...

2 months ago seen See more...

Senior Regulatory Affairs Specialist

Iconma, Llc

Saint Paul, MN

This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...

2 months ago seen See more...

Senior Regulatory Affairs Specialist

Axelon

Saint Paul, MN

This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...

2 months ago seen See more...

Senior Regulatory Affairs Specialist

Collabera

Saint Paul, MN

Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - suppliers should use: Plan and prepare documents for EU MDR Technical File original submiss...

2 months ago seen See more...

Director, Regulatory Affairs Specialty, HIV

Gsk

Olin, NC

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 strategy(ies) in support of the project globally. Lead r...

2 months ago seen See more...

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...

2 months ago seen See more...

Executive Director, Regulatory Affairs

Biospace

San Diego, CA

Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...

2 months ago seen See more...

Director, Regulatory Affairs Companion Diagnostics

Biospace

Basking Ridge, NJ

CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing. At the time of implementation of a CDx study/...

2 months ago seen See more...

VP/Senior VP, Regulatory Affairs

Biospace

San Diego, CA

Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...

2 months ago seen See more...

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...

2 months ago seen See more...

Associate Director, Regulatory Affairs

American Cybersystems

San Rafael, CA

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022). ClearlyRated Client Diamond Award Winner (2020). One of the Largest Certified MBE Companies in the NMSDC Network...

2 months ago seen See more...

Sr. Director, Regulatory Affairs Strategy

Taiho Oncology, Inc.

Pleasanton, CA

$240,000 - $283,000 a year

Responsible to represent the Regulatory Affairs position and decision in assigned Project Teams, due diligence assessments, and compliance remediations for Taiho Oncology, Inc., (TOI), projects including exploratory development an...

2 months ago seen See more...

Senior Regulatory Affairs, Study Start Up Specialist

Cti Clinical Trial Services Inc

Covington, KY

$73K - $92.5K a year

Perform/ oversee compliance assessments against Food and Drug Administration (FDA) lists and documents any FDA activity discovered; notifies Study Manager of any FDA activity documented per CTI SOPs. Compile/ oversee site Regulato...

2 months ago seen See more...

Senior Director, Global Regulatory Intelligence & Policy

Biospace

Basking Ridge, NJ

Leads day-to-day a team of Regulatory Intelligence Policy professionals across all major regions, incl. mentorship, performance mgmt., etc. Supports the team in both Regulatory Intelligence (collection, interpretation and communic...

4 weeks ago seen See more...

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