Senior Regulatory Affairs Officer
Reporting Lines
This position reports into the Principal Regulatory Affairs Officer
Main Function/Responsibilities of the Job
To collate documents and prepare Marketing Authorisation Applications. To co-ordinate cross-functional teams to prepare responses to questions from authorities in a timely manner.
A senior officer must be able to demonstrate the following abilities
- Planning and Organisation
- Priorities own project workload and meet deadlines
- Good communication
- Customer Service to internal staff and external sources
- Liaison with development staff on NPI projects
- Runs meetings for licence projects
- Delivers training and presentations from courses, train junior staff
- Inputs constructive ideas into decision making processes
- Attention to detail and provision of documentation in line with guidance
- Problem solving - uses legal requirements and knowledge to troubleshoot and actively seek ways to prevent issues arising
Primary Task
- Prepares packaging (specials and licensed), reviewing against excipient guidelines, pack check, Braille check and conversant with EU Braille. Submission to external databases, liaison with user test team. Translations. Knowledge of blue box information. Provides guidance to 3rd parties. Final sign off.
- Preparation of Type I and Type II variations including MR. Assessment of PSUR data. Review of junior staff variations.
- Licence preparation - National, Decentralised Procedure, Mutual Recognition, US and 3rd parties. Audits Licences
- Clinical Trial Application collation, submission and responses. Review of junior staff dossiers. Good knowledge of biostudies and review of reports
Applicants must express their wish to be considered for the above post by sending their up-to-date Curriculum Vitae and covering note to recruitment@rosemontpharma.com. Deadline for applications is Friday 18 May 2012.
We are unable to respond all candidates on the success of their applications. Notification of success is given within 14 days of the deadline date.
Rosemont Pharmaceuticals has been awarded the Investors in People (IiP) and the Two Ticks (Positive About Disabled) Accreditation are an Equal Opportunities Employer.
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