CMC Regulatory Strategist

This is a fully remote position, open to applicants in United States.

📋 Description

• Support and advise Rho’s clients on the CMC and associated regulatory elements of integrated development programs, which includes reviewing technical documents, engaging in technical discussions, and collaborating with CDMOs and other vendors.

• Provide leadership, guidance, and support related to CMC regulations to the team.

• Mentor and guide Rho staff on CMC regulatory strategy and product development by offering strategic and tactical advice, fostering team unity and identity, and delivering consistent positive and corrective feedback to team members.

• Actively identify risks and critically evaluate issues impacting the programs while developing contingency plans as necessary.

• Assist in achieving strategic objectives for a program.

• Track the ongoing progress of key CMC deliverables in relation to Global Integrated Product Development Plan goals.

• Ensure efficient, accurate, and timely communication of critical issues and progress to both the team and senior management.

• Take part in planning, preparing, and conducting meetings with regulatory authorities; lead CMC discussions with these authorities.

• Oversee the scope of work, budget, and timelines for external vendors, including consultants and external CMC writers.

• Engage in business development activities, which include identifying and evaluating new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; offer guidance and input for budgets and business submissions of proposals.

⛳️ Requirements

• PhD/PharmD or equivalent demonstration of analytical capability, with a minimum of 12 years of experience in development programs that encompass interrelated clinical, nonclinical, CMC, and regulatory experience.

• Required experience with the FDA; experience with international regulatory authorities (meetings, submissions, strategy) is preferred.

• Strong regulatory intuition and project management skills, coupled with extensive CMC regulatory and product development experience, along with a solid understanding of the interdependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory aspects for integrated development programs from pre-phase 1 to marketing application.

• Outstanding communication skills (written, verbal, interpersonal, and presentation) with the ability to effectively interact with all levels both within and outside the organization; demonstrated ability to establish credibility with professionals on program teams; capability to proactively cultivate constructive interactions among team members to address challenging situations, including tactfully resolving and negotiating conflicts or issues.

• Ability to understand, motivate, and build effective teams.

• Strong critical thinking skills with the capacity to manage multiple projects and priorities while displaying exceptional organizational and time management abilities (both project and personal).

• Proficient in advanced software techniques with relevant programs: MS Project, Visio, Excel, PowerPoint, Word, etc., along with experience working in shared work environments.

🏝️ Benefits

• Medical

• Vision

• Dental

• HSA

• FSA

• EAP

• Life & disability insurance

• 401(k)

• Paid time off

• Holidays

• Parental leave

• Bereavement leave

• Work-life balance