CMC Regulatory Strategist

Key Responsibilities

• Support and advise the CMC and related regulatory components of integrated development programs
• Serve as the lead CMC author 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
• 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)
• 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.

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.

EEO. Veterans/Disabled