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Full-Time Regulatory Affair Director jobs

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REGULATORY AFFAIRS CONSULTANT

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...

CompanyKatalyst Healthcares & Life Sciences
AddressRahway, NJ
CategoryInformation Technology
Job typeFull-Time
Date Posted a month ago See detail

Regulatory Affairs Consultant

Katalyst Healthcares & Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...

a month ago seen See more...

Counsel, Head of Global Regulatory Affairs

An Asset Management Company

Los Angeles, CA

Coordinate TCW's engagement with regulators and other policymakers on Global Regulatory matters, including representing TCW in such engagements. Position TCW to influence policy and regulations; consider TCW's clients and business...

a month ago seen See more...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

New York, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

2 months ago seen See more...

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 months ago seen See more...

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 months ago seen See more...

Manager, Global Regulatory Affairs CMC Submissions Management

Takeda Pharmaceutical

Bronx, NY

$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...

2 months ago seen See more...

Student Affairs Director of Assessment

Liberty University

Remote

Provide leadership for the planning, development, and implementation of the Division of Student Affairs assessment initiatives. Train and advise the Student Affairs Assessment Coordinators as it pertains to their specific assessme...

2 months ago seen See more...

InSPIRE, Marketing, Communications, & Public Affairs Director

Florida State University

Panama City, FL

A masters degree or higher in Marketing, Business Administration, or a related field. Holds one or more professional certification in PCM, CM, APR, CPRC, etc. Experience managing and/or collaborating with cross-functional teams,...

2 months ago seen See more...

Clinical Affairs Director - Full-Time

Signet Health Corporation

El Prado, NM

A full-service, multi-level, substance-dependence treatment program. Medical detox, RTC, IOP-residential sober living. Clients can stay up to a year in our multi-phase program. A holistic, abstinence-based, 12-step curriculum prog...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

Academic Affairs Director Early Childhood Multicultural Education Program

Central New Mexico Community College

Albuquerque, NM

Provides direction, administration and evaluation of academic programs; develops short and long range goals and provides recommendations to ensure alignment with strategic initiatives of the School. Directs program development, pl...

2 months ago seen See more...

Corporate Affairs Director, Research

Amgen

Thousand Oaks, CA

Degree in public relations, communications or journalism experience working in-house or within a PR agency Biotechnology, pharmaceutical or healthcare product public relations including corporate experience highly desired Hands on...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

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...

2 months ago seen See more...

Manager - Regulatory Affairs

Biospace

Lexington, MA

Compile, submit and maintain applications (IND, CTAs, NDAs etc.) to regulatory agencies in support of investigational and marketed products, including compiling and submitting responses to agency queries. Create and maintain produ...

2 months ago seen See more...

Senior Manager, Regulatory Affairs - Proliant Health & Biologicals

Lauridsen Group, Inc.

Ankeny, IA

Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...

2 months ago seen See more...

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...

2 months ago seen See more...

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,...

2 months ago seen See more...

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...

2 months ago seen See more...

Senior Manager Regional Regulatory Affairs

Biospace

King Of Prussia, PA

You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...

2 months ago seen See more...

Regulatory Affairs Senior Program Manager

Biospace

San Francisco, CA

6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...

2 months ago seen See more...

Manager, Regulatory Affairs CMC

Pix11

New York, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

2 months ago seen See more...

Director State Government Affairs (Remote)

Genentech

Washington, DC

$199K - $252K a year

Develop and lead the organization's state lobbying strategies for half of the United States on behalf of Roche Diagnostics.. Create strategic alignment between the interests of business areas and our lobbying and reimbursement act...

4 weeks ago seen See more...

Director, Public & Government Affairs

Nascar

Daytona Beach, FL

Identify, monitor, track and forecast public policy issues related to the organizations business interests. Prepare regular briefings and communications analyzing policy related matters for internal and external stakeholders Mana...

4 weeks ago seen See more...

Assistant Director, Advising and Academic Affairs

Widener University

Chester, PA

$49K - $62K a year

Provide academic advising to Continuing Studies students consistent with established policies, procedures, and program requirements. Establish new relationships to increase enrollment and program participation. Create marketing ma...

4 weeks ago seen See more...

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...

4 weeks ago seen See more...

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...

4 weeks ago seen See more...

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