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Full-Time Regulatory Affair Specialist jobs in Middlesex, NJ

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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 yesterday See detail

Regulatory Affairs Advisor & Liaison

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...

yesterday 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...

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...

2 weeks 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...

2 weeks 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...

4 weeks 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...

System Management & Regulatory Specialist

Pseg

Newark, NJ

Ensure proper execution of technical controls associated with regulatory compliance programs including NERC CIP, SOX, BPU and FERC Affiliate Restrictions. Manage patching cycles for workstations and servers associated with Securit...

a month ago seen See more...

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...

2 months ago seen See more...

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...

2 months 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...

Director, Regulatory Affairs

Byheart

New York, NY

The only U.S.-made infant formula to use organic, grass-fed whole milk. The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk-alpha-lac and lactoferrin-to our ingredients list. T...

2 months ago seen See more...

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...

2 months 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...

2 months 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...

2 months ago seen See more...

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...

2 months 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...

2 months 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...

2 months ago seen See more...

Director, Regulatory Affairs Strategy - Genetic Medicine

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...

2 months 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...

2 months 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...

2 months ago seen See more...

Associate Director, Graduate Affairs Communications Specialist & CRM Administrator

Seton Hall University

Orange, NJ

The incumbent will assist with the general coordination of all graduate enrollment and recruitment efforts by providing critical strategic leadership where technology, data, reporting, and digital communications are concerned. M...

2 months ago seen See more...

CMC Product Quality Compliance Specialist (Regulatory Communications)

Biospace

New York, NY

Responsible for providing writing and strategy support in communications to regulatory agencies including product deviation reports (BPDR, QDR, DPR, etc.), clinical notice of events and agency inspection responses in collaboration...

a month ago seen See more...

Non-Financial Regulatory Reporting- COE Specialist

Bank Of America

New York, NY

$65,000 - $120,000 a year

Develop understanding of the current enterprise and Front-Line Unit / Control Function NFRR governance landscape, structure, and processes within which the NFRR COE currently operates. Engage with key business and operations stake...

a month ago seen See more...

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Top Jobs in Middlesex County, NJ

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What companies are hiring for Full-Time Regulatory Affair Specialist jobs in New Jersey?

The top companies hiring now for Full-Time Regulatory Affair Specialist jobs are Katalyst Healthcares & Life Sciences, LVMH Perfumes & Cosmetics,

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