- Preparation and submission of new product applications.
- Preparation and submission of CMC and administrative variations.
- Preparation and submission of safety variations.
- Preparation and submission of renewals.
- Preparation and submission of change of ownership applications.
- Preparation and submission of Article 61(3) applications.
- Regulatory support for IE markets.
- Preparation and submission of sunset clause applications.
- Communication of regulatory approvals to interested parties.
- Maintenance of PA registered details
- Maintenance of standard operating procedures.
- Timely archiving of regulatory documentation.
- Training internal and external
- Dealing with ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.
- Peer relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
- Action-oriented: Enjoys working hard; is action-oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
- Drive for results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
- Relevant experience in new product, variation, and other regulatory submissions.
- Good understanding of relevant IE legislation.
- Excellent communication and interpersonal skills.
- A proactive approach to problem-solving.
- Good time management skills.
- Flexibility in line with changing priorities.
- Meticulous attention to detail.
- Experience of software packages such as Word, Excel, and Outlook.
- Experience in Pharmaceutical operations arena or community/primary healthcare.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists