Senior Director, Regulatory Affairs CMC, Pharma Tech

Summary

This position manages and supports assigned staff within the department and has demonstrated expertise in regulatory affairs for biological drug candidates throughout development phases. This position serves as the RA-CMC project representative on the global CMC sub team, providing guidance on CMC regulatory and technical issues, and serves as the RA CMC representative to the global RA team.

This position also serves as the Integrated Project Team (IPT) ad hoc member for late stage projects. This position manages and leads multiple assigned projects with consultation on critical issues, with a focus on the most complex late stage projects and post marketing projects, including 3rd party developments. This position provides the identifies critical issues, devises strategic plan, prepares content templates and leads the technical team in preparation of submission documents (e.g., IND, BLA, NDA, Amendments, and Supplements). This position authors regulatory documents where necessary, with consultation on critical issues. This position leads regulatory risk assessment and determines developmental options with minimal consultation.

This position acts as a company liaison with the FDA or other Health Authorities, negotiating with minimal consultation. This position independently leads Health Authority Meetings (e.g., preIND, EOP2, pre-BLA/NDA, Type C), from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. This position demonstrates global RA CMC knowledge through participation in and/or leadership of global projects. This position serves as an acknowledged expert for RA CMC supporting the department and key company initiatives (liaison with PhRMA, USP, ICH, due diligence and regulatory authority inspections). Additionally, this position has direct interaction with research laboratory members and interacts with the Clinical Supplies Organization (CSO) and CMC Management.

This position has strategic interaction with labeling, clinical, non-clinical (Quality Clinical Pharmacology) and toxicology. This position works with highly complex problems requiring expert knowledge in biological drug development to derive innovative solutions and acts as a decision-maker with consultation.

Responsibilities

- Planning for Development and Post Marketing Projects: Manages the most complex CMC development and post marketing projects. Leads submission teams with minimal consultation. Acts as point of contact to cross-functional teams, other departments and other corporate affiliates on RA CMC project issues.
- Execution of Strategy and Submissions: Provides strategic plan with minimal consultation. Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents independently.
- Health Authority Interactions: Identify issues to discuss with Health Authorities and set RA strategy with CMC sub-team. Plan appropriate timing for questions and briefing book development. Liaise with Health Authority on submission, timing, attendees and resolution of queries. Prepare internal and external partners for meeting preparation and facilitate meeting. Oversee preparation of internal meeting minutes and confirm Health Authority minutes for mutual understanding of meeting agreements.
- People Management: Recruit, onboard, mentor, develop, retain, and manage direct and indirect reports and/or matrix teams. Enable communication and alignment within and across functions. Plan projects and ensure resources are available for projects. Manage competing priorities. Able to use leadership and influencing skills to drive and deliver projects in a matrix environment.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- Master's Degree in a scientific discipline required
- PhD in a scientific discipline strongly preferre
- Bachelor's Degree in a scientific discipline required

Experience Qualifications

- 10 or More Years pharmaceutical industry experience required
- 7 or More Years direct CMC regulatory experience required

Travel

Ability to travel up to 20%