6 month initial contract (likely exetnsion and convert to FTE)
Responsibilities:
Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks.
Plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives.
Able to proactively identify risks and devise mitigation strategies.
Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
Perform regulatory research to inform business strategy. Assess and communicate risks.
Assure that there are no significant interruptions to the business due to regulatory compliance issues.
Required Skills, Experience and Education:
Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.
Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.
Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management. Excellent communicator.
Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred.
Preferred Skillset:
Direct experience with oncology drug development highly preferred.
Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.
Direct experience with FDA expedited programs highly preferred.