Sr. Director / Executive Director, Value and Development Consulting at Pharmaceutical Product Development, LLC in Bethesda, MD

JOB DESCRIPTION

The main purpose of this key role is to provide regulatory consulting and strategic advice to internal and external clients and serve as senior regulatory contact to our clients pursuing clinical development in the US.

The primary responsibilities are:

Serve as senior US regulatory strategic lead, providing client portfolio oversight and Regulatory Agency interface

Provide regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products

Provide expert drug development advice to clients both internal and external.

Provide cGXP advice to clients both external and internal

Support PPD consulting as an expert in at least one scientific area

Execute projects as required by the current client base both internal and external.

Assist business development and senior management in securing new business, including collaboration with senior European and APAC regulatory colleagues for clients with assets intended for US development.

Actively develop (with and without the support of the BD organization) new Technical and Regulatory consulting business.

Maintain utilization as required by the PPD consulting organization.

Actively promote a teamwork culture within PPD consulting and across PPD as a whole.

Collaboration as member of PPD/Evidera Development Consulting with Global Product Development, Regulatory Affairs, providing strategic assessment, impact analysis and business inflection points for the client asset, developing a target product profile and key messaging for product labelling to support product critical regulatory development milestones to enable approvable investigational and marketing applications

Serve as senior regulatory contact person for all issues on behalf of client interests, including attendance at Regulatory Authority meetings when needed

*LI-LC1

*LI-remote

Job Qualification

Education and Experience:

Bachelor's degree in a science-related field, an advanced degree is preferred.

10+ years regulatory experience and work experience at US FDA preferred

This role requires a suitable level of experience within a broad range of Regulatory Affairs projects with sound knowledge of Global Regulatory Procedures (Drugs/Biologics)

Strategic US regulatory knowledge and experience across multiple therapeutic areas for Phase I to IV clinical development, non-clinical pharmacology, toxicology, and pharmacokinetics; chemistry, manufacturing and control; clinical protocol designs; relevant regulatory precedents for product approvals; and proven track record for successful negotiations with FDA

Seasoned regulatory reviewer/editor for NDA/BLA CTD Module 2 biopharmaceutics, clinical pharmacology and clinical efficacy and safety summaries and Module 5 CSR/ISE/ISS key messaging

Demonstrable strategic guidance to Health Authority interactions

Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Knowledge, Skills and Abilities:

Broad regulatory affairs experience

Good interpersonal skills

Good knowledge of the Global Regulations

Proven ability to work effectively in a team

Strong knowledge of the Global Regulatory Procedures for clinical trial authorizations or marketing authorizations

Expert knowledge of ICH and global regulatory guidelines

Familiar with computers and their applications

Good organizational and planning skills

Good in-depth knowledge in one of the specialist areas

Able to plan their work at least several months ahead

Able to manage and plan projects and other people

Ability to work autonomously with minimal supervision

Working Conditions and Environment:

Exposure to high pressure, intense concentration needed

Must pay constant attention to detail-visual, mental

Must be able to multi-task constantly

Frequent interaction with clients / associates required

Long, varied hours required occasionally

Travel and rotating shifts required on rare occasions

Exposure to toxic materials on rare occasions