Regulatory Affairs Manager
Amy Lloyd is recruiting for a Regulatory Affairs & Medical Writing Manager on a permanent basis with a privately owned, full-service global Clinical Contract Research Organization, providing professional support to pharmaceutical, biotechnology, medical device and academic businesses and institutions.
The Role: Provide regulatory and medical writing expertise to the company to ensure and guide progression and documentation of clinically safe and efficacious products to the marketplace in a rapid, ethical and globally acceptable manner.
Key responsibilities will include to:
- Be responsible for the medical writing function, oversees the development and preparation of medical information publications, including Clinical Study Reports (CSR), CTD, scientific publications.
- Inform company personnel and encourage an understanding of international regulatory laws and guidelines to instil a company principle of development of safe products within global guidelines.
- Advise company on the requirements and expectations of products in development, providing recommendations on how these requirements and expectations may be achieved.
- Oversee the development, preparation and maintenance of clinical trial applications, clinical trial reports, Orphan Drug Applications, DMFs, Risk Management Plans/Risk Evaluation and Mitigation Strategies, and product license applications (MA, BLA, 510k etc.,), Paediatric Investigation Plans and amendments to ensure timely submission, providing regulatory review, authoring and publishing as required.
- Be responsible for ongoing monitoring of regulatory submissions to make sure relevant amendments are captured and approved, prior to implementation where necessary, ensuring continued compliance.
- Be responsible for approving clinical trial commencement and product shipping for each product and clinical trial through the “Regulatory Green Light” process and communicates this to all relevant groups.
Educational requirements:- Life sciences degree (Masters or PhD preferred) in a scientific field.
- Full Clean Driving licence.
Key skills required:
- Prior clinical trial regulatory affairs experience within a CRO or pharma (2 years' minimum).
- Clear understanding of the requirements and responsibilities for safety reporting in International Pharmaceutical Trials.
- Prior exposure to Protocol Development and Writing and Clinical Study Report (CSR) preparation.
- Medical Device experience is essential.
- GMP and Marketing Authorisation experience would be helpful.
- Excellent personnel management skills.
- Fluent written and oral English language including familiarity with medical terminology.
- Computer Literacy (Word, Excel, PowerPoint, Outlook Express).
For more information or to apply for this position, please contact Amy Lloyd on 01438 905176 or via email on email@example.com. Alternatively, please click on the link below to apply online now. 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 46468 in all correspondence.