Basic qualifications:
• min. 3 years of experience and sound understanding of regulatory affairs, especially in CMC,
• capability to build and maintain a team,
• bachelors degree in scientific or technical field,
• fluent English and Polish (both verbal and written),
• strong interpersonal and communication skills,
• ability to perform multiple tasks, set the right priorities to deliver objectives on time,
• adapting to changing circumstances through priorities reassessment and a disciplined, logical work style.
Preferred qualifications:
• well developed leadership skills,
• negotiation, problem solving and innovation skills,
• practical knowledge of risk management,
• successful delivery of complex projects or project team leadership,
• Project Management experience would be an asset.
Details:
GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies. So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business. Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.
Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).
MSR Team Lead is reporting to Product Lifecycle Regulatory Manager and is accountable for leading and managing the team delivering market specific requirements (MSRs) in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licences worldwide.
MSR Team Lead cooperates with GRPD’s internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRPD’s goals.
In your new role as the MSR Team Lead you will:
• manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment;
• develop and establish formal processes and procedures to meet specified MSRs business objectives;
• ensure high standard of submissions, act as quality control point;
• identify risks to quality and/or timely completion of projects, resolving any issues and escalating items to be resolved at a higher management level;
• drive continuous process improvement within areas of your influence;
• monitor regulatory intelligence and act proactively on identified changes to regulatory requirements worldwide;
• build and maintain quality relations with your internal and external stakeholders;
• work closely with your peers and manager to drive standardization across the business.
Closing date for applications: 10th April 2016.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.
Contact information:
You may apply for this position online by selecting the Apply now button.
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GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...
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