Director, Regulatory Affairs

Veristat•North Carolina, NC

3d•$195,000 - $223,000•Remote

About The Position

Director Regulatory Affairs, responsible for strategic and operational regulatory consulting for client companies. The Director RA will be client facing and will be responsible amongst others for: Strategic Advice to clients, with focus on early development through to NDA/ BLA. Independent preparation of regulatory documentation such as US IND, NDA/BLA modules, ODD, Fast track / other designations, FDA advice requests. Scientific Interaction with internal cross functional teams. Client facing & Agency point of contact: Interaction with clients and FDA, lead interactions with Health Authorities. Internal BD & marketing facing role.

Requirements

Bachelor’s degree in science, toxicology, pharmacology, engineering or related field
10 years of relevant experience working directly for a CRO/ Pharmaceutical Company
minimum 5 years of experience leading regulatory development projects
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 and 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 with 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

Nice To Haves

Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials.

Responsibilities

Strategic Advice to clients, with focus on early development through to NDA/ BLA
Independent preparation of regulatory documentation such as US IND, NDA/BLA modules, ODD, Fast track / other designations, FDA advice requests
Scientific Interaction with internal cross functional teams
Client facing & Agency point of contact: Interaction with clients and FDA, lead interactions with Health Authorities
Internal BD & marketing facing role