Our client is a clinical-stage pharmaceutical company. They have asked us to assist them in their search for a Senior Manager, Regulatory Affairs.
Major tasks and responsibilities will include:
Acts as regulatory project manager of US and EU regulatory submissions.
Creates and maintains regulatory submissions trackers and timelines.
Schedules team meetings, agenda, meeting materials, minutes and follow-ups with team members on action items.
Acts as regulatory lead on clinical projects.
Is responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs.
Contributes to the development and implementation of clinical, pre-clinical, and CMC regulatory strategy for projects in all stages of development.
Coordinates all aspects of regulatory submissions relevant to assigned projects or programs.
Manages and mentors regulatory team members. Assigns and prioritizes work while providing oversight and guidance to the team members
Identifies and assesses regulatory risks for assigned projects or programs.
Prepares and delivers effective presentations for both internal and external audiences.
Contacts regulatory agencies relevant to assigned projects or programs, as appropriate.
Participates and contributes in Health Authority meetings.
Represents regulatory on relevant project teams.
We seek candidates with the following qualifications:
PhD or MS degree required. Focus on Life/Health Sciences preferred.
Requires a minimum of 8 years of pharmaceutical industry experience.
Must have a minimum of 5 years of regulatory experience.
Requires strong project management skills including familiarity with PM toolkits.
Must be able to represent the department in project teams.
Requires strong organizational skills, including the ability to prioritize personal and direct reports workload.
Must have strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
Must have experience interfacing with relevant regulatory authorities.
Requires experience in the preparation of major regulatory submissions and supportive amendments or supplements, and understanding of applicable regulations.
Requires experience interpreting regulations, guidelines, policy statements, etc.
If interested, please email your resume as a Word attachment to us, reference 3809. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlons list of Top 50 Healthcare & Life Sciences Search Firms.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.