Associate Director of Regulatory Affairs (remote-based)
- Experience Level
Hobson Prior are seeking for a remote Associate Director of Regulatory Affairs of FDA Regulated Products for a CRO. As the RA Director, you will be responsible for interaction with team across a number of development programs.
Please note that to be considered for this role you must have the right to work in this location.
- Develop regulatory strategy for projects including creative solutions to complex problems.
- Knowledge of current regulations, laws and guidance both US and ex-US.
- Ability to take a leadership position on project teams.
- Responsible for interaction with team across a number of development programs.
- Independent planning, coordination and preparation of document packages for regulatory submissions, such as Pre-IND meeting requests and packages, INDs, CTDs, EOP2, and/or position papers.
- Independently initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, up to and including travel to, and direct discussions with the appropriate regulatory agency.
- Provide project, department, and company guidance and training based on current and emerging FDA regulatory affairs requirements, regulations, and processes, and focus on improved regulatory efficiency and effectiveness.
- Excellent communication skills, both oral and written, with proficiency in MS Word, Excel, PowerPoint, and Project required.
- Must be organized, team oriented, detail oriented, and able to handle multiple projects concurrently.
- A minimum of a BS in Chemistry or Life Sciences.
- A minimum of 6-8 years pharmaceutical and/or medical device industry experience.
- A minimum of 4 years of regulatory affairs in FDA regulated products.
- RAPS certification preferred.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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