Olly Care is recruiting for a Pharmaceutical Module 3 Regulatory Dossier Writer to join a specialist pharmaceutical company Hull on a 6 month contract initially.
The role involves supporting the development of exciting new and existing projects in the field of addiction therapy and associated co-morbidities. The Dossier Development Team is responsible for the generation, ownership and oversight of the Module 3 and M2 Quality Overall Summary, throughout its lifecycle from Phase 1 inception through to post approval lifecycle management.
The main purpose of the role will be to:
- Author Module 3 dossier sections in support of regulatory submissions for existing product development and new market license applications.
- Ensure the documentation is of the highest quality and any issues highlighted to internal or third party stakeholders in a timely manner.
- Author ASMF/DMF sections to support maintenance of existing drug substance licenses and new applications.
- Author regulatory annual reports for existing product maintenance, in time to meet agency deadlines.
- Request documentation from internal functions and Contract Manufacturing Organisations (CMOs) in time to ensure that submission deadlines are met.
- Check and track stability data provided from third party CMOs to identify unexpected trends and ensure compliance with registered specifications.
- Accurately review CTD documents prepared by other members of the Dossier Team and the wider R and D function. Including transcription checking of data and written technical information.
- Communicate effectively across different functions within the company (including R and D, Regulatory and Technical Supply) located at different sites in the UK and US, to develop high quality CMC documentation.
- Communicate effectively with third party CMOs.
- Assist in the preparation of responses to agency questions and requests for information.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A science-based degree
- Previous experience working in a technical or regulatory role within the pharmaceutical industry or similar industry, with a proven track record of delivering high quality work to tight deadlines.
- Experience of the preparation of technical documentation.
- Experience of preparation of CTD documentation for regulatory submissions and/or experience in a technical role within the pharmaceutical industry (such as analytical development) and a desire to transition into a more regulatory based role within R and D.
- Good organisational skills and the ability to progress different activities concurrently, as well as a high level of diligence and attention to detail.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL39760 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 4th August 2017
- Expires: 1st September 2017
- Reference: CL39760