Associate Director/Director, Regulatory Affairs
Our client is a precision therapy company. They have asked us to assist them in a search for an Associate Director/Director, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Manages day-to-day regulatory aspects of clinical development program.
- Is accountable for all relevant Health Authority submissions and approvals for assigned program(s).
- Plans for and leads preparation efforts for health authority meetings.
- Represents the GRS function on global development teams.
- Develops, supervises, and implements long and short-term product regulatory strategies.
- Provides guidance to external programs vendors and consultants.
- Supports the development of new regulatory requirements or guidance documents.
- Mentors junior regulatory team members.
- A Bachelor’s degree required. An advanced scientific degree is a plus.
- Requires a minimum of six years in pharmaceutical industry experience, with at least six years of drug development experience in a Regulatory Affairs function/department.
- A solid understanding of drug development process and US regulatory requirements is required.
- Requires the ability to understand and interpret sophisticated scientific issues across projects and therapy area(s) as it relates to regulatory requirements and strategy.
- Experience in oncology/rare-diseases drug development is a plus.
- Experience filing INDs, CTAs, and/or NDA/BLAs to FDA and ex-US regulatory agencies is desired.
- Knowledge of EU, Canada, ROW, and post-marketing regulatory requirements is preferred.
- Must be able to work well with others and communicate with senior leadership.
- Strong oral and written communication skills, and negotiation skills are required.
- Must be willing to set and drive aggressive project timelines.
- Requires strategic thinking and the ability to propose innovative solutions to regulatory problems.
- Must be proficient in Microsoft Word, Project, PowerPoint, and Adobe Acrobat.
- Must be a team player, who listens effectively and invites response and discussion.
- Requires the ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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