Regulatory Affairs Director(All Levels) - Toxicology Regulatory Advising at Pharmaceutical Product Development (PPD)

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)

Job Qualification

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 process improvements
• Excellent organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
• Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
• Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
• Capable of independently learning new technologies
• Capable of effectively acting as a liaison with other departments