Junior Regulatory Specialist

Job description

Details:
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).

In this role you have an opportunity to work closely with GMS Programs group who deliver Supply Chain Transformation and major programmes being driven by GMS that are vital to our success as we continue to seek opportunities to simplify and drive compliance.
If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone's life, then this opportunity is for you.

In your new role you will:
• Take part in a challenging projects related to the product source transfers and other programs driven by GMS,
• Support the Team in multiple regulatory activities and in preparation of appropriate CMC modules and variation dossiers for GSK products,
• Acquire knowledge of regulations, guidelines, procedures and policies relating to the registration and manufacturing of pharmaceutical products,
• Communicate regularly with Regulatory Manager/Team Lead to help in identification of any issues with business impact,
• Monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
• Interact with global regulatory groups and local operating companies to deliver compliant and timely dossiers,
• Build and maintain quality relations with your internal and external stakeholders.

Closing date for applications: 11/09/17

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.

Please note that interviews for these roles will commence from ASAP, due to the short recruitment period we would appreciate your flexibility in attending interviews asap.

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
• Bachelors degree in chemistry, pharmacy or other related science or technical field,
• Fluent Polish and English (both verbal and written),
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs,
• Flexible and analytical thinking,
• Detail-oriented, with emphasis on accuracy and completeness,
• Excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization.

Preferred qualifications:
• Strong computer related skills (Microsoft suite including Excel, and Word),
• Work experience in an international environment would be an additional advantage.

We offer the opportunity to gain experience in well-known company, to cooperate with international environment where you can have an access to cutting-edge technology and work in friendly atmosphere. We provide an attractive remuneration package and benefits, as well as the prospects of a comprehensive professional development.