|Sector||Pharmaceuticals & Biotechnology|
The primary responsibilities of this position include the following. The incumbent may perform other duties, as assigned:
- Directly communicate with Country RA team members to develop global regulatory project plans, including a detailed list of submission deliverables, dependencies, approval timing and cost.
- Compile regulatory documentation in support of medical device and drug submissions in accordance with local regulatory requirements.
- Create / maintain overall schedule for global registration activities, and communicate accomplishments and risks to global project team.
- Coordinate responses to regulatory authority queries with strict deadlines.
- Support Country RA to maintain and update existing regulatory authorizations
- Prepare / update product labeling (i.e., create red-lines, route documents through review / approval process).
To perform this job successfully, an individual must possess the following:
• Excellent written and verbal communication skills
• Ability to manage complex / multiple projects and deadlines effectively
• Ability to identify risks and escalate when necessary
• Negotiation skills
• Past experience supporting global Pharmaceutical registrations; medical device global regulatory experience is advantageous
• Scientific knowledge
• Technical system skills (e.g. word processing, spreadsheets, Microsoft Project, databases, online research, SharePoint)
Bachelor’s degree or country equivalent in engineering, chemistry, or related scientific discipline with a minimum of 5 years regulatory or equivalent experience within a pharmaceutical company or similar organization.