Rho · 5 hours ago
Associate Director / Director, Regulatory Strategy
United States
Full-time
Remote
Lead/Staff, Director/Executive
$180K/yr - $220K/yr
5+ years expRho is a company that inspires innovation in the life sciences and is seeking an Associate Director/Director of Regulatory Strategy. In this strategic role, you will provide leadership and guidance for interdisciplinary pharmaceutical, biologic, and medical device development programs, while managing multiple projects and ensuring regulatory submissions are completed accurately and on time.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Serve as an integrated product development and regulatory expert at Rho, responsible for product development activities and services required to support the development programs and regulatory submissions of Rho's clients, including gap analyses, strategic planning, development of integrated regulatory and clinical strategies and development plans, design of clinical studies, and authorship and review of study protocols, study reports, and regulatory submissions
On behalf of Rho's clients, lead integrated pharmaceutical, biologic, and medical device product development programs consisting of clinical, nonclinical, chemistry, manufacturing and controls, and regulatory components
Provide leadership, guidance, and support to teams, programs, or projects of large scope, as well as to the Program Management discipline within the company
Mentor and advise staff in areas of expertise 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 develops contingency plans as needed
Facilitate achievement of strategic goals for a program
Monitor ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans
Ensure effective, accurate and timely communication of key issues and progress to project stakeholders and senior management
Manage the strategic, regulatory authorship, biostatistical, and data submission components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions
Author Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other complex regulatory documents
Develop and review clinical study protocols, investigator's brochures, clinical study reports, and other key clinical development documents
Lead the planning, preparation, and conduct of regulatory authority meetings, and participates in discussions with regulatory authorities as appropriate
Manage scope of work, budget, and timelines for external vendors, including consultants, external medical writers, nonclinical toxicology houses, and other vendors
Moderate regulatory authority meetings
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; serve as a proposal leader for commercial proposals with specific responsibility for the development and articulation of the technical strategy sections of the proposal; provide guidance and input to the budgets and business submissions of proposals
Mentor other technical leads in business development and proposal creation activities
Qualification
Required
PhD/PharmD or equivalent demonstration of analytical ability and a minimum of 5-8 years in development programs that include inter-related clinical, nonclinical, CMC and regulatory experience; Regulatory Affairs Certification (RAC) desired
Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) desired
Excellent written, verbal, and interpersonal communication skills 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 understand and motivate others and build effective 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
Excellent presentation and critical thinking skills
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, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments
Benefits
Medical
Vision
Dental
HSA
FSA
EAP
Life & disability insurance
401(k)
Paid time off
Holidays
Parental leave
Bereavement leave
Company
Rho
Rho is a pharmaceuticals company that offers clinical drug development services.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown1984-10-24Angel
Leadership Team
Laura Helms Reece
Chief Executive Officer
Russ Helms
Chief Strategist
Recent News
2026-01-05
2025-11-15
Company data provided by crunchbase