Regulatory Professional – Regulatory Affairs

Role Overview

• Support preparation, publishing and submission of regulatory files and responses to health authorities worldwide.
• Support planning and conducting of regulatory interactions with authorities.
• Contribute to development and maintenance of core labelling across the product lifecycle.
• Drive and support process updates, system/tool maintenance and optimisation projects.

Requirements

• Must have Master of Science or other relevant professional degree required.
• Must have Approximately 6 to 8 years’ experience in regulatory affairs or related fields.
• Must have Familiarity with submission planning and RIM, regulatory dossier preparation (MAA/NDA/BLA, CTA/IND), labelling development and pharmacovigilance documentation.
• Should have demonstrated ability to evaluate regulatory options, maintain cross functional relationships, share knowledge and suggest process improvements.
• Cultural awareness and the ability to work effectively across global teams are essential.

Benefits

• opportunities to learn and develop
• benefits are designed with your career and life stage in mind