- 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 labelling
- Bachelor’s degree or country equivalent in engineering, chemistry, or related scientific discipline
- A minimum of 5 years of regulatory or equivalent experience within a pharmaceutical company or similar organization
- A medical device global regulatory experience is advantageous
- Project Management Experience / PMP Certification will be an advantage
- Excellent written and verbal communication skills
- Ability to manage complex / multiple projects and deadlines effectively
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
Bezoek pauwelsconsulting.com voor meer informatie over de vacature Regulatory Affairs Associate of solliciteer online op de vacature Regulatory Affairs Associate.
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