Regulatory Affairs Professional Transdermal Specialist

Regulatory Affairs Professional -Transdermal Specialist

Location: Yorkshire and Humberside

Salary: Dependant on experience - competitive

Background:

Global Leader

The provision of age-appropriate medicines and dosage forms is a key area of activity and scrutiny for regulatory authorities.

In order to keep abreast of current and proposed regulation in the area of Topical and Transdermal medicines, we are seeking a forward thinking regulatory affairs professional to lead and provide input to teams in this key area.

Occasional travel abroad

Key responsibilities are as follows:

To monitor relevant legislation and guidelines (EU / US / ANZ/ MENA/ LATAM/Asia) and provide a quarterly brief to senior regulatory managers and others as identified.
* To be accountable for regulatory input to all Topical/ Transdermal projects and to lead these regulatory submissions.
* To input into the clinical strategy for Topical and Transdermal projects.
* To provide input to global roll out of existing products.
* To ensure consistency of regulatory approach across all RB licensed products used topically.
* To interact with key stakeholders including colleagues in Global Marketing, Global and European Medical, European and Country Regulatory and Regional Groups.
* To lead the company response to public consultations, e.g. on any relevant guidelines.

Experience Required:

The successful applicant will have:
* Experience of regulatory environment for Topical medicines
* Proven ability to manage complex regulatory issues
* Experience of CTD/ e-CDT dossier complication
* MRP & DCP experience
* Good working knowledge of clinical methodologies used to register Topical medicines

To find out more about Real Staffing please visit www.realstaffing.com