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MAA Submission Project Manager

Employer
Barrington James
Location
Remote working - no travel required
Salary
Competitive Rate
Start date
1 Mar 2021
Closing date
31 Mar 2021

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Job Details

I am currently supporting a BioPharma Consultancy who specialises in CMC development, GMP Manufacturing, Regulatory Affairs, Quality Assurance and CDMO Search and Management. My Client is seeking a MAA Submission Project Manager to work with them on freelance basis for at least 12 months with a full FTE. This Consultant is required immediately and will be supporting a cross-functional MAA Submission team lead by the Client. This position is fully remote working and has no travel required.

Responsibilities include:

  • Will partner with the Clients submissions team leader to manage business deliverables associated with the MAA submission and ensure compliance and on-time delivery of the agreed tasks according to the plan
  • Will be accountable for developing and maintaining overall project timelines and MAA submission plans, monitoring and tracking team progress with the MAA documents and deliverables
  • Will be facilitating team and sub-team meetings, and ensuring communication within the team ensuring results-oriented meetings and positive team dynamics – including sending out agendas and minutes on a timely basis
  • Needs to communicate effectively with team members, senior leaders, and key stakeholders on assigned program/task progress, issues, risks and mitigation plans
  • Builds and maintains a positive and dynamic working relationship with the submissions team leader, team members, other external stakeholders, and especially the client
  • Applies project management expertise and methodologies based on world-class program management combined with regulatory expertise and experience
  • Shall organize and channel all communication for maximum efficiency, full transparency, and positive team dynamics
  • Shall organize and maintain all MAA documentation current and available for all team members
  • Prepare regular updates, status reports and metrics for the MAA submission project for submission team, leadership and client

Requirements:

  • BSc or MSc in Science or Pharmacy
  • Project Management education and certification such as CPM, PPM, MPM
  • 10+ years pharmaceutical regulatory affairs experience in the pharmaceutical industry, regulatory agency or consulting company
  • 5+ years of previous IND/IMPD, BLA, NDA, and MAA submission experience
  • Previous MAA and other submission Project Management experience
  • Good understanding of regulatory guidance as pertaining to MAA submissions
  • Desirable: good understanding of eCTD and submission publishing

I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding the above position then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.

Alternatively you can reach me on Linked In or e-mail me on JASmith@barringtonjames.com.

If you are interested in discussing any of my other vacancies, or simply want to be made aware of opportunities as they arise then please contact me or have a look at available jobs on the Barrington James Website.

I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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