Junior Regulatory Specialist

    • Luboń, Poland

Site Name: Poznan Grunwaldzka
Posted Date: Apr 15 2020
The Global Regulatory Platform and Delivery team are creating new roles in the CMC Variations Poznan team. The purpose for the role will be timely maintenance of post approval CMC changes for Finished Product and Active Pharmaceutical Ingredients, providing expertise and support to Local Operating Companies with respect to post approval changes and responses to Regulatory Agency questions about Products.

Junior Regulatory Specialist is accountable for preparing and compiling regulatory dossiers, delivering market specific requirements in line with existing business needs, strategies, goals and objectives in order to support GSK's product licenses worldwide.
As our structure is growing, we are looking for several successful candidates to join our teams.

Key responsibilities:
• Managing CMC (Chemistry, Manufacturing and Control) Variations assignments for Finished Products and Active Pharmaceutical Ingredients for Pharma and Vaccines portfolios
• Complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets
• Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
• Building good relationships with internal and external stakeholders

Basic qualifications:
• Bachelor's degree in biotechnology, biology, chemistry, pharmacy or other related science or technical field
• Attention to detail, excellent organization and time management skills
• Very good written and verbal communication skills in English
• Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues
• Strong will to learn new things
• Ability to organize your own work schedule and to keep deadlines

Preferred Qualifications:
• Work experience in fields related to regulatory affairs would be an additional advantage

Why GSK?:
• Established job in an international, well-known pharmaceutical company
• Possibilities of development within the role and company's structure
• Wide range of benefits (Medical Plan, Life Insurance, Sport and recreation cards, Recreation allowance etc.)
• Canteen for employees at site (with discounts)
• Flexible working hours
• Partly remote work
• Corporate culture based on our values: patient focus, integrity, respect and transparency

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.

Thank you very much for your interest in development opportunities with GlaxoSmithKline.


If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Back to top