regulatory Jobs in Philadephia, PA

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Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLC

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Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents.
Posted 17 hours ago | Updated 5 hours ago

Sr. Regulatory Operations Specialist

Zachary Piper Solutions, LLC

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Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop content plans for IND & CTA dossiers. Lead interactions with external publishing teams to compile IND or CTA submissions, including reports and
Posted 1 day ago | Updated 5 hours ago

Engineer, Sr/Principle Regulatory - EN

Constellation Energy

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Kennett Square, Pennsylvania, USA

Full-time

COMPANY OVERVIEW As the nation's largest producer of clean, carbon-free energy, Constellation is a company purposely-built to meet the challenges of the climate crisis. Constellation has been the leader in clean energy production for more than a decade and we are growing our company and capabilities. Now, we're accelerating, speeding our low-carbon or no-carbon power to more people in more places, day and night, providing our customers and communities with options to buy, manage and use energy
Posted 2 days ago | Updated 19 hours ago

SAP PRA Consultant (Regulatory Reporting)

Activesoft, Inc.

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Remote

Contract

SAP PRA Consultant (Regulatory Reporting ) Occasional Travel to Houston TX (Argentina, Brazil) Job Description: 1) Revenue Accounting and Disbursement 2) Production Accounting :Gas Booking and contracting, allocation, Well level accounting for production 3) Regulatory Reporting govt and federal agency including annual reporting.
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Posted 1 day ago

Regulatory Affairs Specialist III

Fusion Life Sciences

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Remote

Contract

Job Title: Regulatory Affairs Specialist (Remote) Summary: Seeking a fluent French speaker to guide EU MDR project teams. Responsible for preparing and submitting EU MDR documentation for medical devices (Class , IIa, IIb, I sterile or reusable) for CE marking and EU commercial release. Collaborate with cross-functional teams and Notified Bodies. Supervision: Reports to Sr. Manager or Director of Regulatory Affairs. No supervisory responsibilities. Essential Duties: Ensure EU MDR compliance for
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Posted 21 hours ago | Updated 21 hours ago

SAP Revenue / Production Accounting & Regulatory Reporting Consultant (PRA)

Activesoft, Inc.

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Remote

Contract

SAP Revenue/Production Accounting/Regulatory Reporting Consultant (Oil & Gas) Location: Houston, TX/Argentina/Brazil (for workshops)+ (Travel expenses) Duration: ASAP to 12/13/2024 with the possibility of an extension Job Description: 1) Revenue Accounting and Disbursement 2) Production Accounting :Gas Booking and contracting, allocation, Well level accounting for production 3) Regulatory Reporting govt and federal agency including annual reporting.
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Posted 1 day ago | Updated 1 day ago

Regulatory/ Pharmacovigilance Associate (REMOTE)

NetSource, Inc.

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Remote

Contract

Please note that this is a 1 year contract position. HIGHLIGHTED SKILLS: - Role can be 100% REMOTE - May travel for a possible mandatory meeting onsite (Raritan, NJ) for 1-2 days, not very often at all - Bachelors Degree required - Pharmacovigilance experience needed - Must be flexible / adaptive - Must be able to problem solve, and know when to ask for help - Working within the Global Environment / Global Teams - Regulatory Affairs experience - MAIN ASPECT OF ROLE: Support Aggregate Tracking p
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Posted 2 days ago | Updated 1 day ago

Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

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Remote

Contract

Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities: -Authoring US FDA 510(k) submission using eSTAR submission tool.
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Posted 8 days ago | Updated 8 days ago

Technical Writer with ISO Compliance Regulatory experience

BayOne Solutions

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Remote

Contract

Technical Writer Location: Remote work Duration: 7 months Job description: We are seeking a Technical Writer to join our team and support the IT Operations project tracks within the ISO initiative. In this role, you will collaborate closely with the IT Ops project management team to conduct working sessions and engage with external stakeholders across various ISO tracks. The immediate focus of this position is to work collaboratively with the Infrastructure and Technology, IT Business Engagement