Global Regulatory Affair Vice President - Clinical

Page Executive; United Kingdom; On-site; Confidential; Full time

Job summary

Un acteur majeur des sciences de la vie recherche un Vice-Président des Affaires Réglementaires Cliniques. Le candidat idéal possédera une expérience significative dans les affaires réglementaires, avec un accent particulier sur les médicaments contre le diabète et l'obésité. L'opportunité offre un environnement de travail innovant et une culture d'entreprise embrassante, ainsi que des perspectives d'évolution professionnelle significatives.

Benefits

Package de rémunération complet incluant 401k et assurance médicale

Possibilités de croissance de carrière

Culture d'entreprise innovante et accueillante

Qualifications

• 10+ ans d'expérience en affaires réglementaires dans le secteur biopharmaceutique.
• Expertise avérée dans les processus d'approbation FDA et EMA.
• Expérience en gestion des soumissions réglementaires à l'échelle mondiale.

Responsibilities

• Développer et exécuter des stratégies réglementaires pour les médicaments contre les maladies métaboliques.
• Gérer les soumissions réglementaires, y compris INDs, CTAs, NDAs et BLAs.
• Diriger les interactions avec les agences réglementaires.

Skills

Regulatory affairs

Clinical regulatory affairs

Risk assessment

Cross-functional teamwork

Job description

• To drive regulatory strategy and the drug approval process from FDA, EMA
• Their major pipeline focus on diabetes and obesity

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.

Job Description

• 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

A successful 'Global Regulatory Affairs Vice President - Clinical' should have:

• 10+ 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 drive 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.

What's on Offer

• Salary range of $350,000 - $440,000
• Comprehensive benefits package including 401k and medical insurance
• Innovative and embracive company culture
• Extensive career growth opportunities

If you are an experienced clinical Regulatory Affairs expert in the Life Sciences industry and are excited about the opportunity to make a significant impact on a global scale, we encourage you to apply for the 'Global Regulatory Affairs Vice President - Clinical' position.