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 Want to know company name or location? BrightOwl managed [?] Still accepting applications
Project is currently here
- 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
Work from home: Not Allowed
International Travel: Yes
No. of Positions: 1
Skills and Expertise
Is a big plus
Detail requirement and what we offer
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.