Regulatory Consultant

Role

* You will be responsible for the management of labeling processes on assigned products across countries in their assigned regions.
* Monitor regional labeling regulations; oversee product labeling requirements and deliverables across Affiliates.
* Interface with and support the product Global Labeling Manager, the EU or EM Regulatory Strategist and Affiliate Regulatory Manager.
* Participate in Global Labeling Sub-Team meetings, be responsible for the logistical aspects of implementation of SmPC text in the EU consistent with Global objectives.

* Position reports to the Above Country Affiliate Labeling Lead, with a strong matrix relationship to Regional Regulatory Lead and the Affiliate Regulatory Managers.

Requirements

* Have knowledge of appropriate regional regulations and guidelines pertaining to labeling systems and processes in ICH regions and demonstrate the ability to understand implications to National labeling and constructively interface with Affiliates on local regulatory requirements for label implementation
* Be able to demonstrate experience in interfacing, negotiating and problem solving with technical teams/lines that support the development, maintenance and testing of labeling systems, formats and processes
* A Bachelors Degree, preferably in Pharmacy, Life Sciences or Information Technology required. Advanced academic qualification/degree is desired but not required; equivalent relevant professional experience will be considered

Skills and experience

* Have Demonstrated successful business experience at the Sr. Associate / Manager Role Level.
* Demonstrated project management skills and attention to detail required.
* Proven ability to function autonomously at all levels and in a team environment.

* Experience working in Regulatory Affairs, preferably in an EU Country office, Experience in logistical aspects e.g. submission compilation and publishing

* Proven accountability, and demonstrated excellence in interpersonal, communication.

Note: If you know anyone that you feel suits this role, please forward this on; we offer £200 worth of vouchers if your referral is placed successfully.To find out more about Real Staffing please visit www.realstaffing.com