Regulatory Affairs Contract Position

Responsibilities:

-Ensure application of and support for new registrations, renewals, variations and regulatory authority feedback.
-Ensure a quality audit for all Medicinal and medical device dossiers is conducted.
-Ensure notification of class I, II medical devices to the appropriate Competent Authority

Monitor, collect and interpret regulatory issues and trends that potentially will impact products, policies and procedures.

-Interface with relevant government authorities (where needed) and ensure enquiries received from regulatory authorities in reference to submissions are addressed by working closely with relevant functioning groups. This includes MRP/DCP submissions in EU as well as Class I-II medical devices.
-Advise Global Category Development, Regional Scientific Services and Business on regulatory requirements and regulatory impact during early phases of the NPD process for medicinal and medical device positioned projects intended for launch.
-Work collaboratively with appropriate company personnel and contractors (when required) to define global regulatory dossiers for the medicinal and medical device positioned projects.

Experience Required;

-Experience with Health Care Product development
-Extensive experience in Regulatory Affairs
-Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders.
-Prior experience in US OTC and medical devices (Class I-III) is preferred Solid experience in medicinal EU requirements and CTD structure is preferred.
-Prior experience in dealing with EU Medicinal Agency (EMEA) and/or MHRA is desirable.
-If you believe you have the relevant experience, or you know someone who does, then please

contact Joseph on 02077587322, or email on

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