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Full-Time Senior Associate Regulatory Affair jobs

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SENIOR ASSOCIATE - REGULATORY AFFAIRS

Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...

CompanyBiospace
AddressPrinceton, NJ
CategoryInformation Technology
Job typeFull time
Date Posted 4 weeks ago See detail

Senior Associate - Regulatory Affairs

Biospace

Princeton, NJ

Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...

4 weeks ago seen See more...

Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination

Biospace

North Chicago, IL

Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...

4 weeks ago seen See more...

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...

3 days 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...

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...

7 days ago seen See more...

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,...

2 weeks ago seen See more...

Associate Director, Regulatory Affairs Innovation

Biospace

Irvine, CA

Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...

4 weeks ago seen See more...

Senior Manager/Associate Director, Regulatory Strategy

Biospace

Boston, MA

Throughour in-depth understanding of the biological pathways involved inmineralization, we are pursuing the development of therapeutics to address theunderlying causes of these debilitating diseases. You will develop and implement...

4 weeks ago seen See more...

Senior Associate, Regulatory Oversight Management

Bny Mellon

Pittsburgh, PA

Communicates with internal and external parties as needed and makes recommendations on necessary procedural/control changes on Regulatory Oversight Management matters. Gathers data and prepares materials for more senior team membe...

a month ago seen See more...

Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH

Abbott Laboratories

Lake Forest, IL

$72,700 - $145,300 a year

Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...

4 weeks ago seen See more...

Senior Manager, Regulatory Affairs Vendor Governance

Biospace

California, United States

Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...

4 weeks ago seen See more...

Financial Regulatory Senior Associate or Counse...

A Global Law Firm

Washington, DC

Creative, innovative, resourceful and motivated. A team player. Welcoming of accountability and responsibility. An excellent writer and oral communicator. Capable of interacting with clients and preparing client-ready work product...

a month ago seen See more...

Associate Director, Regulatory Affairs - Inflammation & Immunology

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...

Associate Director, Regulatory Affairs - Inflammation & Immunology

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...

Associate Director, Regulatory Affairs Advertising and Promotion

Biospace

California, United States

Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...

a month ago seen See more...

Associate Director, Regulatory Affairs - Inflammation & Immunology

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...

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...

a month 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...

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 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...

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...

Counsel Senior Manager - Legal Entity Governance: Public, Regulatory and Corporate Affairs

Wells Fargo

Charlotte, NC

Work on matters for the subsidiaries of Wells Fargo & Company, including support for all aspects of Legal Entity corporate governance, planning and preparing for board and committee meetings, overseeing board evaluations for subsi...

a month ago seen See more...

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