Regulatory Affairs Director (All Levels) Napoli

Regulatory Affairs Director (All Levels)
Napoli
Campania, Napoli

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.

You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD clinical research services is the place to be.

Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.

PPD has an exciting opportunity for a senior toxicologist to join our team as an Associate Director/Director/Senior Director, Regulatory Affairs within our Regulatory Technical Advising group.

In this role you will be a pivotal team member with at least 5-8 years of experience for an Associate Director, 8-10 years for Director, and over 10 years for Senior Director in pharmaceutical toxicology, responsible for driving and leading nonclinical (pharmacology/toxicology) strategy for our clients.

This position is based in the EMEA region, can be remote, or based in an office depending on location.

In this role, you will conduct strategic planning and nonclinical program management to enable successful development of small molecules and biologics in stages of development throughout the product lifecycle.

You will feel confident providing nonclinical regulatory advice and executing projects while acting as liaison with internal and external clients.

What are the essential functions of the role?

- Responsible for developing and implementing nonclinical (pharmacology/toxicology) strategy and submission plans for assigned projects/products, together with clinical, pharmacokinetics, and bioanalytical colleague

- Provide consultation to clients on the design and management of nonclinical development programs from early discovery though regulatory submission for client program

- Identify required nonclinical studies for regulatory submissions and ensure the nonclinical program supports the manufacturing program and the intended clinical program

- Provide nonclinical advising and meeting support for successful interactions with global regulatory authorities

- Prepare/review pre-meeting packages (e. g. , pre-IND and Scientific Advice briefing documents) and defend nonclinical programs to regulatory agencies

- Prepare/review pharmacology/toxicology sections of submission

- Review and analyze nonclinical data

- Provide consulting support to assist clients with placement and oversight of GLP and non-GLP studies at preclinical CRO

- Provide toxicology support for CMC activities (such as impurity and excipient evaluations and risk assessments for extractable/leachable programs)

Education and Experience:

At least 5-8 years for an Associate Director, 8-10 years for Director, or over 10 years for Senior Director of relevant nonclinical (toxicology) experience, including as a toxicologist in the pharmaceutical/biotechnology industry or at a regulatory agency

A broad background of nonclinical regulatory experience on products from discovery/early development through post-approval, gained from working in the pharmaceutical industry or at a regulatory agency in one of the ICH regions

Toxicology certification (Diplomate, American Board of Toxicology or European Registered Toxicologist) highly desirable but not required

Small molecules and biologics expertise (cell and gene therapy experience is highly desirable but not required)

Proven track record of successful authoring /contribution to delivering nonclinical sections of INDs/CTAs and marketing authorizations for new biological and/or chemical entities

Experience with regulatory agency meeting preparation and attendance, including negotiation with regulatory agency representatives

Proven project management experience and success building relationships across a diverse stakeholder team

Knowledge of ICH, FDA, and EMA guidances and GLP requirements

Knowledge, Skills and Abilities:

Excellent English language communication and negotiation skills, as well as local language where applicable, both oral and written

Excellent understanding of global drug development throughout the product lifecycle, with emphasis on nonclinical disciplines; superior understanding of ICH and other global nonclinical regulatory guidances.

Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills

Capable of driving innovation in developing new ideas related to pro