CMC Regulatory Strategist

Join us in redefining what it means to work for a CRO.

When you work at Rho, it's more than just a job-you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work-and each other.

You'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

We are currently hiring a Director, CMC Strategy to join our team! As a Director, CMC strategy, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. You will serve as Rho's senior CMC expert and ensures full CMC support for Rho's project teams, including CMC-specific project tasks such as developing and tracking project budget, timelines, resources, and deliverables, as well as authoring and reviewing CMC regulatory documents for clinical trial applications and marketing applications, regulatory agency meeting packages, CMC gap analyses, and other documents as needed.

Our Regulatory Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Key Responsibilities:

• On behalf of Rho's clients, support and advis e the CMC and related regulatory components of integrated development programs, including the review of technical documents, participation in technical discussions, and collaborations with CDMOs and other vendors.
• Provide CMC regulatory-related leadership, guidance, and support to a team
• Mentor and advise Rho staff in CMC regulatory strategy and product development by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
• Proactively identify risks and critically analyze problems affecting the programs and develop contingency plans as needed
• Facilitate achievement of strategic goals for a program
• Monitor ongoing progress of key CMC deliverables against Global Integrated Product Development Plan goals
• Ensure effective, accurate and timely communication of key issues and progress to the team and senior management
• Participate in the planning, preparation, and conduct of regulatory authority meetings; lead CMC discussions with regulatory authorities
• Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers
• Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; provide guidance and input to the budgets and business submissions of proposals

Requirements

• PhD/PharmD or equivalent demonstration of analytical ability and a minimum of 12 years in development programs that include inter-related clinical, nonclinical, CMC and regulatory experience
• Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) is desired
• Excellent regulatory intuition and project management acumen with an in-depth CMC regulatory and product development experience, and a firm understanding of the dependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory for integrated development programs across all phases from pre-phase 1 to marketing application.
• Excellent communication skills (written, verbal, interpersonal, and presentation) and the ability to interact effectively with all levels both within and outside the company; proven ability to establish credibility with professionals on program teams; ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure
• Ability to understand and motivate others and build effective teams*
• Critical thinking skills with the ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
• Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments

Benefits

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $190,000-$210,000 per year.

EOE. Veterans/Disabled