Project Manager, Regulatory Affairs: - Ireland
This is an exciting time at Acorn Regulatory. We are actively seeking to recruit a Project Manager to work with our Regulatory Affairs specialists.
The Project Manager of Regulatory Affairs will report to the Managing Director and is responsible for developing and maintaining regulatory timelines throughout a product lifecycle, tracking global regulatory submissions and commitments, assisting with meeting coordination and other tasks. Excellent written and verbal communications skills are a must. Managing complex issues with minimal supervision and ability to efficiently multi-task will be necessary. The ideal candidate will have excellent written and effective verbal communication skills, proficient in project management, is flexible, and able to work in a fast paced environment.
- Bachelor’s or Master’s degree in a scientific discipline or equivalent
- Project management certification is desirable
- Able to simultaneously handle multiple projects and exercise good judgment in prioritising tasks
- Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups
- Strong communication skills (oral, written, and interpersonal) and the ability to proactively identify and recommend solutions to problems
- High level of attention to detail
- Candidate must possess at least 3 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry with demonstrated increasing expertise and responsibility.
- Proficient with all Microsoft Office applications, Adobe and document management templates.
ROLES AND RESPONSIBILITIES
- Develop and manage detailed project plans for specific tasks and integrated regulatory development programs to track project progress to completion.
- Measure project performance/progress using appropriate systems, tools and techniques.
- Assess risk and impact to timelines on an on-going basis. Report and escalate issues to management as necessary.
- Inform Regulatory colleagues of relevant changes to project scope.
- Ensure projects are delivered on-time.
- Create and maintain project documentation (i.e. project charter, action logs, decision trackers, etc.)
- Proactively contribute to the development and implementation of regulatory strategy for assigned projects.
- Monitor company progress toward fulfillment of regulatory commitments.
If you would like to have an initial confidential conversation about this role then please contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706 or if you would like to submit your CV then you can do so by emailing: email@example.com