$200K — $250K *
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
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
Valid through: 4/13/2021