Senior Regulatory Consultant
For a confidential discussion call Nikolay on +44(0) 207 255 6665 or e-mail nikolay.dimitrov@secpharma.com
Location: London area (Office based)
Salary/Rate: up to £50 per hour
Duration: 6 months (+ extension)
My client, a large pharmaceutical company is looking for an experienced Regulatory Affairs professional to join their team as a Regulatory Consultant on a 6 months contract basis. The ideal candidate will have 5 years of experience and an expert knowledge of UK / Ireland / Malta Regulatory procedures.
As a Regulatory Consultant, your purpose will be to Deliver competitive licences for UK/Ireland/Malta promoted and cornerstone brands including driving regulatory strategy for new initiatives. Ensuring regulatory compliance for defined product and project responsibilities, including project leadership.
KEY TASKS
*Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
*Develop professional working relationships with assessors and administrative staff within the regulatory agencies
*Prepare high quality regulatory applications and regulatory responses for UK/Ireland/Malta
*Defend existing labelling and provide regulatory input into patent defence strategies
*Ensure timely submission of licence variations that affect product labelling for assigned UK/Ireland/Malta licences
*Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs
*Provide regulatory input/solutions to stock issues
*Liaise with Operations to manage pack changes and ensure labelling compliance
*Actively contribute to cross-functional team working within the Medical & Regulatory Directorate and other areas of the business
*Provide strategic regulatory input relating to promoted and cornerstone brands
*Take a lead role in project management and delivery
*Ensure focused regulatory input into new product development
*Understand and promote UK/Irish business needs into European strategies on drug development and regulatory filings/issues
*Ensure appropriate cross functional input into the delivery of optimal licence strategies
*Provide opportunities for product changes following product assessments and regulatory strategy
*Responsible for planning and executing workload for the defined product responsibilities and agreeing plan with Regulatory Team Manager
*Keep up-to-date with developments in the Regulatory Environment and share this knowledge across the department and beyond, in the business interest
*Actively contribute to development / mentoring of regulatory executives
QUALIFICATIONS
*Life Sciences Degree or appropriate professional qualifications
*Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
Nikolay Dimitrov
Pharmaceutical Division
Tel:
+44 (0)20 7255 6665
+33 (0)170807489
+49 (0)69 222 22 888
+41 (0)44 580 3717
Email: Nikolay.Dimitrov@secpharma.com
Web: www.secrecruitment.com