Remote Sr. Dir Regulatory Affairs Strategy Consultant

Company: Global Channel Management,Inc
Location: Atlanta
Posted on: November 22, 2021

Job Description:

Sr. Dir Regulatory Affairs Strategy Consultant needs 10-12 years of regulatory affairs experience in the pharmaceutical industry, with several years of demonstrable experience within oncology
Sr. Dir Regulatory Affairs Strategy Consultant requires:
Bachelors degree in a relevant scientific discipline.
Masters or an advanced degree (PhD, PharmD) is preferred.
Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements
Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC). Experience with regulatory filings in oncology is required.
Strong written and oral communication skills and the ability to interact effectively with project teams.
Manage regulatory affairs activities and provide leadership in a hands-on fashion while utilizing a strategic approach in all aspects of global compliance

Sr. Dir Regulatory Affairs Strategy Consultant duties:
Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.
Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies.
May assist in the development of the strategic & technical expertise of regulatory colleagues who are involved in supporting filings.

Keywords: Global Channel Management,Inc, Atlanta , Remote Sr. Dir Regulatory Affairs Strategy Consultant, Professions , Atlanta, Georgia