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