Overview
Director, Regulatory Affairs at Veristat leads regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products, translating regulatory requirements into practical applications to ensure the success of clinical trials and regulatory submissions. S/he serves on Veristat multidisciplinary project teams, provides independent regulatory strategy advice, guidance on regulatory agency interactions, manages agency communications, leads the preparation of submissions, and builds strong rapport with clients. The Director, Regulatory Affairs acts as a point of escalation for challenging regulatory issues and mentors and supervises more junior team members.
Responsibilities
- Oversee regulatory and cross-functional projects; provide strategic and operational support to clients in decision-making, filings, and maintenance of healthcare products.
- Serve on multidisciplinary project teams; provide independent regulatory strategy advice and guidance on regulatory agency interactions.
- Manage agency communications, lead preparation of submissions, and maintain strong client rapport.
- Act as escalation point for challenging regulatory issues; mentor and supervise junior team members.
- Oversee regulatory aspects of projects and teams, manage internal staff, and interact with executive-level staff; maintain optimal department processes and implement project-specific and department-wide strategies.
What We Offer
- Estimated hiring range for this role is $180k-$220k plus applicable bonus; this range is USA-specific and varies by region based on local market data.
- Benefits vary by location and may include remote work, flexible time off, paid holidays, medical insurance, tuition reimbursement, retirement plans.
What We Look For
- Bachelor's degree in science, toxicology, pharmacology, engineering or related field; advanced degree (Master's, PhD, PharmD) preferred with applied training relevant to clinical trials.
- 10 years of relevant CRO/pharmaceutical industry experience, with at least 8 years in supervisory roles.
- Thorough knowledge of ICH GCP and applicable regulatory rules; understanding of medical terminology, clinical trials, and clinical research.
- Excellent written and verbal communication skills; familiarity with complex study designs and regulatory requirements for Phase I-IV trials.
- Knowledge of CRO/pharma industry regulatory obligations and relationships.
- Proven leadership and supervisory abilities; strong interpersonal and organizational skills; ability to work independently and in a team.
- Travel up to 25% (local and international).
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr