Director, Regulatory Affairs

New Yesterday

: The Director, Regulatory Affairs leads and manages assigned 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 will serve on Veristat multidisciplinary project teams, provide independent regulatory strategy advice, advice on regulatory agency interactions, manage agency communications, lead the preparation of submissions, and create strong rapport with clients. The Director Regulatory Affairs acts as a point of escalation for challenging regulatory issues and serves as a mentor and project supervisor to more junior team members. The Director Regulatory Affairs will oversee the Regulatory aspects of projects and project teams through the management of internal staff and through interaction with Executive-level staff. They are responsible for the maintenance of optimal department processes, the implementation of project-specific strategies, and the development and implementation of department strategies to increase productivity and quality. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture - 70% remote workforce, 66% women-led teams What we offer The estimated hiring range for this role is $180k -220k plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. Benefits vary by location and may include: Remote working 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 Scientific degree such as Master's degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials. 10 years of relevant experience working directly for a CRO/ Pharmaceutical Company, with a minimum 8 years of supervisory experience required. Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research. Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required. In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies. Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff. Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications. Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment. Driving/Travel requirements - Travel up to 25% (Local & International) Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Location:
Oklahoma City, OK, United States
Job Type:
FullTime
Category:
Management & Operations

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