CMC Regulatory Strategist

Rho Inc

About The Position

Rho is a Contract Research Organization (CRO) that fosters a collaborative and supportive environment, encouraging curiosity and fresh approaches. The company prides itself on stability—financial, workforce, and corporate—providing a secure environment for innovation and career development. Rho is currently seeking a Director, CMC Strategy to provide strategic and tactical leadership to clients and project teams. This role supports interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. The Director will serve as Rho’s senior CMC expert, ensuring full CMC support for project teams, including managing budgets, timelines, resources, and deliverables. Key responsibilities also include authoring and reviewing CMC regulatory documents for clinical trial applications, marketing applications, regulatory agency meeting packages, and CMC gap analyses.

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.
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.

Nice To Haves

Experience with ex-US regulatory authorities (meetings, submissions, strategy) is desired.

Responsibilities

Support and advise 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.