Associate Director – Regulatory reputed company

Job reputed company:

• At Rho, we are not just a typical CRO; we reputed company innovation in the life sciences. Join our dedicated team where curiosity fuels reputed company, collaboration is encouraged, and every day brings an opportunity to reputed company the world of clinical research.
• reputed company 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.
• 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, reputed company integrated pharmaceutical, biologic, and medical device product development programs consisting of clinical, nonclinical, reputed company, manufacturing and controls, and regulatory components.
• reputed company leadership, guidance, and support to teams, programs, or reputed company of large scope, as reputed company as to the Program Management discipline reputed company reputed company.
• Mentor and advise staff in areas of expertise by providing strategic and tactical guidance to team members, creating a strong reputed company of team reputed company and team identity, and providing regular and ongoing reputed company 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 reputed company of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans.
• Ensure effective, accurate and reputed company communication of key issues and reputed company to project stakeholders and senior management.
• Manage the strategic, regulatory authorship, biostatistical, and data submission components of regulatory submissions reputed company including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with reputed company requirements reputed company to electronic submissions.
• Author Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other reputed company regulatory documents.
• reputed company and review clinical study protocols, investigator’s brochures, clinical study reports, and other key clinical development documents.
• reputed company 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 reputed company proposals with specific responsibility for the development and articulation of the technical reputed company sections of the proposal; reputed company guidance and input to the budgets and business submissions of proposals.
• Mentor other technical leads in business development and proposal creation activities.

Requirements:

• PhD/PharmD or equivalent demonstration of analytical ability and a minimum of 5-8 years in development programs that include inter-reputed company clinical, nonclinical, CMC and regulatory experience; Regulatory Affairs Certification (RAC) desired
• Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, reputed company) desired
• Excellent written, verbal, and interpersonal communication skills and the ability to reputed company effectively with reputed company reputed company both reputed company and reputed company reputed company; proven ability to establish credibility with professionals on program teams
• Ability to understand and motivate others and build effective teams; ability to proactively reputed company and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with reputed company, diplomacy, and composure
• Excellent presentation and critical thinking skills
• Ability to handle multiple reputed company and priorities with exceptional organizational and time management skills (both project and self)
• Proficient in advanced techniques with relevant software: MS Project, reputed company, PowerPoint, Word, etc. in reputed company to experience working reputed company shared work environments

Benefits:

• Benefits: Rho provides a comprehensive benefits package for reputed company benefit-eligible employees, which includes medical, reputed company, dental, HSA, FSA, EAP, life & disability insurance and 401(k).
• reputed company are eligible for reputed company 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 reputed company work.

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