Global Regulatory Affair Vice President - ClinicalPage Executive • NJ, United States
Global Regulatory Affair Vice President - Clinical
Page Executive • NJ, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_description10+ years of regulatory affairs experience in biopharma, with a focus on metabolic disease indications (diabetes, obesity, etc.). Proven track record of successful FDA and EMA interactions driving regulatory approvals. Strong expertise in clinical regulatory affairs, particularly in late-stage development and approval processes. Experience managing global regulatory submissions and working with cross-functional teams. Salary range of $350,000 - $440,000 Comprehensive benefits package including 401k and medical insurance Innovative and embracive company culture Extensive career growth opportunities Seniority level : Executive Employment type : Full-time Job function : Legal Industries : Pharmaceutical Manufacturing, Accounting, and Financial Services
Global Regulatory Affair Vice President - Clinical
Global Regulatory Affair Vice President - Clinical role at Page Executive. Our client is a large Life Sciences organization known for quality and global presence.
About Our Client
Our client is a large organization in the Life Sciences industry. Known for its innovative approach to quality, they have an established presence globally and continue to make significant contributions to the field of Life Sciences.
Responsibilities
- Develop and execute regulatory strategies for metabolic disease drug development, ensuring compliance with FDA, EMA, and global regulatory requirements.
- Drive interactions with regulatory agencies, including pre-IND / IND submissions, NDA / BLA filings, advisory meetings, and approval processes.
- Oversee clinical regulatory affairs (RA), ensuring alignment between clinical development and regulatory expectations.
- Provide strategic guidance on regulatory pathways, risk assessment, and regulatory trends affecting metabolic disease treatments. Cross-functionally with clinical, medical, and commercial teams to optimize regulatory positioning.
- Manage regulatory submissions, including INDs, CTAs, NDAs, and BLAs, ensuring timely approvals.
The Successful Applicant
What's on Offer
Contact
Quote job ref : JN-022025-6675680
Additional Details
Location : Cranford, NJ
Referrals increase your chances of interviewing at Page Executive by 2x
#J-18808-Ljbffr
serp_jobs.job_alerts.create_a_job
President Regulatory • NJ, United States