Regulatory Affairs Director (All Levels)

PPD; Napoli; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

PPD is seeking a Regulatory Affairs Associate Director / Director / Senior Director in Toxicology to support nonclinical development strategies and regulatory submissions. Candidates should have extensive experience in toxicology and project management, contributing significant expertise to help clients navigate complex regulatory environments across the EMEA region. This role offers a chance to join a collaborative team committed to improving health through innovative therapies.

Competenze

• Minimum 5-8 years for Associate Director, 8-10 years for Director, over 10 years for Senior Director in toxicology.
• Experience in regulatory submissions (INDs, CTAs).
• Knowledge of ICH, FDA, EMA guidances, and GLP standards.

Mansioni

• Developing nonclinical strategy and submission plans for projects/products.
• Consulting clients on nonclinical development program design.
• Providing nonclinical regulatory advice and managing projects.

Conoscenze

Strategic Thinking

Project Management

Excellent Communication

Negotiation Skills

Analytical Skills

Formazione

PhD or equivalent in Toxicology

Descrizione del lavoro

Regulatory Affairs Associate Director / Director / Senior Director, Toxicology Regulatory Advising - based in the EMEA region.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. Join a collaborative and winning culture committed to delivering life-saving therapies efficiently.

If you are a strategic thinker, planner, and multitasker comfortable working independently or in a team, and capable of delivering compliant results with sound judgment, PPD is the place for you. Our global regulatory experts contribute strategies and knowledge to help clients navigate complex regulatory environments and accelerate access to therapies.

PPD offers an exciting opportunity for a senior toxicologist to join our Regulatory Technical Advising group as an Associate Director / Director / Senior Director, Regulatory Affairs. You will be a key team member with at least 5-8 years of experience for Associate Director, 8-10 years for Director, and over 10 years for Senior Director in pharmaceutical toxicology, focusing on nonclinical (pharmacology/toxicology) strategy for our clients. The role is based in the EMEA region and can be remote or office-based depending on location.

Your responsibilities will include strategic planning and program management for nonclinical development of small molecules and biologics throughout their lifecycle. You will provide nonclinical regulatory advice and manage projects while liaising with internal and external stakeholders.

Essential functions include:

• Developing and implementing nonclinical strategy and submission plans for projects/products, coordinating with clinical, pharmacokinetics, and bioanalytical teams
• Consulting clients on nonclinical development program design and management from discovery to regulatory submission
• Identifying necessary nonclinical studies for regulatory submissions and ensuring alignment with manufacturing and clinical plans
• Providing nonclinical advice and support for interactions with global regulatory authorities
• Preparing and reviewing pre-meeting documents and defending nonclinical programs during regulatory meetings
• Reviewing pharmacology and toxicology sections of submissions
• Analyzing nonclinical data and providing related consulting support
• Overseeing GLP and non-GLP studies at CROs
• Supporting CMC activities with toxicology expertise, including impurity and extractable/leachable assessments

Education and Experience:

Minimum 5-8 years for Associate Director, 8-10 years for Director, over 10 years for Senior Director in relevant nonclinical toxicology, with experience as a toxicologist in pharma or regulatory agencies. Broad background in nonclinical regulatory work across product stages from discovery to post-approval in the ICH regions. Toxicology certification is desirable but not mandatory. Experience with small molecules and biologics, including cell and gene therapy, is preferred. Proven success in authoring or contributing to regulatory submissions (INDs, CTAs, marketing authorizations). Experience with regulatory meetings and negotiations. Strong project management skills and ability to build stakeholder relationships. Knowledge of ICH, FDA, EMA guidances, and GLP standards.

Knowledge, Skills, and Abilities:

Excellent communication and negotiation skills in English and local languages. Deep understanding of global drug development and nonclinical regulations. Strong analytical skills, budgeting, and forecasting abilities. Innovative thinking in regulatory strategies.