Regulatory Affairs Specialist Project Lead I

8-10 years

Not Disclosed

Remote, USA

10 June 3, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Specialist Project Lead I

Location: Bridgewater, NJ (Fully Remote)

Duration: Contract till October 2024 with the possibility of extension

Job Overview

The Regulatory Affairs Specialist Project Lead I will oversee and manage regulatory projects with a focus on US FDA Advisory Committee (ADCOM) preparation. Experience in immunology products is preferred, but any ADCOM experience will be considered.

Key Responsibilities

Project Management: Lead and manage regulatory projects, ensuring compliance with US FDA regulations.
ADCOM Preparation: Directly handle US FDA Advisory Committee preparation.
Collaboration: Work closely with cross-functional teams to ensure successful regulatory submissions and approvals.
Documentation: Prepare, review, and submit regulatory documents in accordance with FDA requirements.

Requirements

Education:
- Required: BS/BA degree in a relevant scientific discipline.
- Preferred: Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or a related field).
Experience:
- At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D.
- A minimum of 5 years of relevant Regulatory Affairs experience (regional and/or global).

Preferred Qualifications

Experience with immunology products.
Strong knowledge of regulatory requirements and processes.
Excellent project management and organizational skills.
Effective communication and interpersonal skills.

Additional Information

Work Arrangement: Fully remote.
Contract Duration: Till October 2024, with the possibility of extension.

For more information or to apply, please visit our careers page or contact us directly.

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