Senior Manager Regulatory Affairs - 6 months Contract, Brussels, BE

Reference: JM10572A

Expiry Date: 08-11-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Contractor

Location:
Belgium

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Job Description

Senior Manager Regulatory Affairs - 6 months Contract, Brussels, BE

As a Regulatory Affairs Expert you will supports the Regulatory Lead in planning and executing the necessary regulatory activities to progress our Project portfolio with the ultimate aim of obtaining marketing authorizations in the EU as well as globally.

This is a 6 months contract (potentially renewable) with a global, R&D based company located in Brussels. The rate is competitive and there is flexibility to work from home 2-3 days per week (post Covid 19).

Responsibilities will include, but will not be limited to:

  • Responsible for providing regulatory expertise and strategy for designated the Projects.
  • Assume responsibilities for contact with 3rd party partners, building strong relationships for assigned project(s), in line with the Regulatory Lead.
  • Handle major variations with the project team and with Regulatory Lead: eCTD content, modules review/input, responsible for Module 1, submission planning and label update.
  • Product development: agency interactions (pre-submission meeting, scientific advice ... etc), orphan designation, CTAs, study protocol/IBs/CSR input and review, PIPs.
  • Support and deliver quality regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.

Required qualifications:

  • Experience of EU regional regulatory procedures and legislation related to drug development and clinical trial applications as well as lifecycle management will be ideal.
  • From 5 to 7 years of experience preferred in this field.
  • Strong Project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions.
  • Analytical - logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions.
  • Integrity - overriding commitment to integrity and high standards in self and others.
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person.  Works effectively in ambiguous situations.
  • Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions.
  • Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate.

To Apply!

To apply for this role, please contact me, Javier Monfort, on +44 (0)207 801 3385 or Oli Dimitrov on +44 (0)207 801 3388, or e-mail me at jmm@advtalent.com in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs. Alternatively, please press the red “Apply for position” button and follow the registration process.

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