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REGULATORY AFFAIRS ADVISOR & LIAISON

Relish interacting with senior leaders and regulatory agencies. Thrive in a dynamic, fast-paced environment where priorities often change. Possess strong critical thinking, written and verbal communication skills. Understand and a...

CompanyCapital One
AddressNew York, NY
CategoryInformation Technology
Date Posted just now See detail

Regulatory Affairs Advisor & Liaison New

Capital One

New York, NY

Relish interacting with senior leaders and regulatory agencies. Thrive in a dynamic, fast-paced environment where priorities often change. Possess strong critical thinking, written and verbal communication skills. Understand and a...

Regulatory Affairs Consultant

Katalyst Healthcares And 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 te...

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...

Executive Assistant, Regulatory Affairs

Edwards Lifesciences

Irvine, CA

$69,000 - $94,000 a year

Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Whether you are coordinating key meetings and events, su...

Global Regulatory Affairs - Senior Financial Analyst

Northern Trust

Chicago, IL

Unspecified

Develop and maintain financial models to support strategic initiatives. Analyze financial data and reports to identify trends, issues, and opportunities. Prepare regular reporting to management for review. Collaborate with cross-f...

Sr Manager/AD Regulatory Affairs CMC (small molecules)

Biospace

San Francisco, CA

Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions. Oversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulato...

Manager, Global Regulatory Affairs, Marketed Products

Biospace

Boston, MA

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 TakedasPrivacy Noticeand Terms of U...

Senior Manager, Regulatory Affairs Project Management and Strategic Planning

Biospace

Remote

You will lead cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase development programs by providing effective Project...

Senior Manager, Public Policy, International Government and Regulatory Affairs (IGRA)- Hybrid

Biospace

Rockville, MD

We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abiliti...

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...

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...

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...

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...

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,...

Quality and Regulatory Systems Implementation -Manager-Consulting

York State Department Of Labor

New York, NY

Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.). Regulatory Affairs (regulatory submissions, Health Registration Managemen...

Quality and Regulatory Systems Implementation -Manager-Consulting

York State Department Of Labor

New York, NY

Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.). Regulatory Affairs (regulatory submissions, Health Registration Managemen...

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...

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...

Consumer Affairs Consultant I

Terra Staffing

Richardson, TX

Provide excellent customer service for questions related to product information. Deescalate and resolve customer concerns. Help educate consumers on equipment and warranty information. Record and document customer calls through co...

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...

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...

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...

Sr. Regulatory Affairs Specialist (Andover or Mansfield, MA)

Smith & Nephew

Andover, MA

$115,000 - $130,000 a year

Coordinates associated registration or submissions leading to market clearance/approval. Provide regulatory direction to project teams for product development/design control related activities. Drafting, authoring and submitting P...

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...

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...

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...

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...

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...

Regulatory Affairs Manager (CMC Site)

Biospace

New Albany, OH

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...

Manager, Global Regulatory Affairs CMC

Biospace

Boston, 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 in Cambridge, MA with the...