BrightOwl Loader Loading

Head Of Regulatory Affairs - Belgium   The Head of Regulatory Affairs defines the product development regulatory strategy and ensures its implementation for a complete and efficient development of the ASIT biotech drug products. He/she defines the strategic and scientific content of the releva

BrightOwl managed [?] Still accepting applications
112 Facebook  Linkedin

Functional titles : Director Regulatory Affairs ,  Regulatory Affairs Consultant
Project Types : Permanent position ,
FTE : 100 %
Min.Experience : 10 year
Start Date : ASAP
End Date : N/A
Posted on : 13 June 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
Step 3
BrightOwl Interview
Step 4
Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

  • Coordinate, prepare and follow-up the submission of regulatory documents for national or international clinical studies.
  • Prepare or maintain technical files as necessary to obtain and sustain product approvals.
  • Interact with regulatory agencies all along the development phase and the lifetime of the product.
  • Participate to product-related discussions and provides in-depth strategic, scientific and RA input, for technical aspects, for clinical/labelling/Non-Clinical or procedural aspects of given project.
  • Provide critical review for technical, for clinical/labelling/non-clinical or procedural regulatory documents, Global Regulatory Plans and Key Message Summaries.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Draft product labelling, instruction leaflets and packaging.
  • Participate in internal or external audits, inspections and provide post-inspection follow-up information as requested
  • Facilitate and deliver the regulatory strategy to support the lifecycle of the productss for technical, for clinical/labelling/non-clinical or procedural aspects
  • Write or update standard operating procedures, work instructions, and policies related to RA.
  • Is responsible for Regulatory Intelligence
  • Develop and motivate collaborators within RA team and coordinate with multidisciplinary teams to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
  • Ensure planning and proper organization of activities in line with the company milestones

Others

Project FTE 100%
Work from home:   Not Allowed
International Travel:   Yes
No. of Positions:   1

Personality

Approachability Communicative Collaboration Innovative thinking Organization Strategic thinking Result Oriented

Knowledge

Regulatory affairs Registration of the product

Skills and Expertise

Regulatory documentation Regulatory submissions Manage regulatory activities Develop regulatory strategy Prepare regulatory documents Report deaths to regulatory authorities

Degree

Ph.D.

Languages

English
Full Proficiency
Mandatory
French
Elementary Proficiency
Is a big plus

Desired Skills & Experience

  • Scientific degree in life sciences or pharmacy
  • Minimum 10 years of experience in the field of Regulatory Affairs
  • Solid knowledge of ICH guidelines, EU and US regulations required for Regulatory submissions and Good Clinical Practice (GCP) guidelines
  • Experience of face to face meeting with Health Authorities
  • Good people management and leadership
  • Stress resistant
  • Good ability to take responsibilities
  • High accountability
  • Good reporting skills
  • Capable to summarize complex data
  • Strong organizational and communication skills (oral and written)
  • Analytic capacity, details minded, meticulous
  • Solid writing and editorial skills
  • Team player, strong interpersonal skills
  • Able to work independently
  • Demonstrated ability to deliver results with appropriate quality and according to timelines of the company
  • Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner

Fluent in French & English, with excellent writing skills.

Project opportunities at this company

No more opportunities available