Director, Regulatory Affairs

Director, Regulatory Affairs page is loaded## Director, Regulatory Affairs locations:
New Jersey time type:
Full time posted on:
Posted 2 Days Agojob requisition :
R
- *
* Job Description:

**** Director, Regulatory Affairs
** 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

Learn more about our core values !
** What we offer
*** 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)
* Automated Decision Making:
All applicants are reviewed by a member of the Veristat Talent Acquisition team;
Veristat does not utilize an automated decision-making process.*#LI-RD1

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr