Associate Director / Director, Regulatory Strategy

Rho Inc

4d•$180,000 - $220,000

About The Position

At Rho, we are not just a typical CRO; we inspire innovation in the life sciences. Join our dedicated team where curiosity fuels progress, collaboration is encouraged, and every day brings an opportunity to impact the world of clinical research. We are excited to announce an opening for the position of Associate Director/Director of Regulatory Strategy. In this strategic role, you will 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 need in-depth regulatory and pharmaceutical 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. In addition to serving in a management and mentoring role for Rho scientific personnel, you will also directly serve as Project Leader to manage multiple projects for a range of products, performing project tasks such as developing and tracking project budget, timelines, resources, and deliverables, as well as authoring and reviewing regulatory submission documents for clinical trial applications and marketing applications, clinical protocols and study reports, Integrated Summaries of Safety and Efficacy, regulatory agency meeting packages, and other documents as needed.

Requirements

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

Nice To Haves

Regulatory Affairs Certification (RAC) desired
Experience with ex-US regulatory authorities (meetings, submissions, strategy) desired

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

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

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume