Regulatory Affairs Associate |£34000 - £35000 per annum
Regulatory
Permanent
London

Safety & Regulatory Affairs Associate

Additional Information

Location: Mansfield
Salary: up to £35,000 + Benefits
Hours: Monday – Friday 37.5 hours
Job Type: Permanent

Role Purpose
To provide professional Drug Safety & Regulatory services to the company in the form of Medical Information Services, Marketing Material, Promotion Meeting and Sponsorship review and approval to ABPI Standards. Manage Medical Device Vigilance & device complaints with the Vigilance Officer.

Relationships

* The Safety & Regulatory Affairs Associate will interact with most departments within the company on a daily basis and will work closely with the Corporate QREM and Medical Departments.
* As part of the ABPI Compliance Review important interfaces will be with the UK Sales and Marketing departments. Also with external Health Care Professionals.
* Co-operation will be required with the Medicines and Healthcare products Regulatory Agency (MHRA), The Health Products Regulatory Authority (HPRA) in relation to submission of Medical Device Incidents.
* Association of British Pharmaceutical Industry (ABPI) in relation to compliance of the Sales and Promotion of Pharmaceuticals.

Main Accountabilities
The Safety & Regulatory Affairs Associate is responsible for the following, as identified to support the Regulatory Compliance Manager.
* To review Marketing Materials for compliance with ABPI Code of Conduct, through full review of the material submitted and references quoted to ensure that the materials are accurate, balanced and reflect the most up to date information related to the products(s).
* Advise the Marketing department with a summary of all issues and work with them to provide alternative wording/message. This would include any materials from 3rd Parties where the company is involved in any marketing.
* Review and approve, where appropriate, proposed External Scientific or Promotional Meetings for Compliance with ABPI standards and advise of any issues.
* Review requests for Sponsorship to ensure compliance to ABPI standards.
* Prepare and maintain Abbreviated Prescribing Information for licensed products.
* Review and approve, where appropriate, proposed External or Promotional Meetings for Compliance with ABPI standards and to advise of any issues.
* Review requests for Sponsorship to ensure compliance to ABPI standards.
* Provide Medical Information Service for all company products ie PD solution, Acute solutions and HD.
* Manage AEs, Medical Device Vigilance & device complaints with the Vigilance Officer & RAA
* Maintain SPCs and PIL and update relevant databases accordingly.
* Develop regulatory affairs internal policies and procedures
* Attend and partake in internal and external audits related to your job

Experience and Qualifications

Required Training & education
* Relevant scientific degree – life sciences, e.g. chemistry, biology, pharmacy, pharmacology, nursing.
* Working experience/knowledge of PV & Regulatory affairs would be advantageous

Required professional experience
* Proven experience in the Pharmaceutical Industry and/or Medical Device industry of reviewing pharmaceutical marketing materials for compliance to the ABPI Code of Conduct.
* Proven experience and training in the provision of Medical Information.
* Experience in the submission of licence applications and variations for pharmaceutical products would be desirable.
* Experience in the handling of Medical Device Complaints would be preferable but training can be provided.
*
Personal requirements
* Good communication skills both written and oral. Ability to communicate with a range of customers, internal and external.
* Ability to present information in a coherent fashion to varying audiences. Computer literate.
* Good time management – ability to work on several issues simultaneously and re-prioritise work in rapidly changing environment.
* Ability to work under pressure.
* Adaptable – able to respond to changing customer demands in an innovative manner.
* Ability to work both as an individual and as a member of a team.
* Ability to read and understand technical aspects of articles related to pharmaceutical products

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