CTA/IND Regulatory Specialist

The CTA/IND Regulatory Specialist at GlaxoSmithKline will be an integral part of our Regulatory Affairs team. We are looking for an organized and detail-oriented individual who can effectively assess and manage the regulatory aspects of our clinical trials and investigations. In this role, you will be responsible for providing support to the clinical teams and developing solutions to ensure compliance. To be successful in this position, you must have excellent communication skills, strong project management abilities, and the ability to interact with all levels of management. If you are a professional with a passion for regulatory affairs, we encourage you to apply.Required Qualifications:• Bachelor's Degree in Regulatory Affairs, Life Sciences, or related field • At least 5 years of experience in Regulatory Affairs• Knowledge of regulatory requirements and current Good Clinical Practice (GCP)• Ability to work independently and effectively manage multiple projects• Excellent written and verbal communication skills• Outstanding organizational and problem-solving abilities

Responsibilities:

1. Assess and manage the regulatory aspects of clinical trials and investigations.
2. Provide support to the clinical teams and develop solutions to ensure compliance.
3. Establish and maintain effective communication with all levels of management.
4. Prepare and review documents related to regulatory submissions.
5. Monitor timelines and ensure that all regulatory milestones are met.
6. Analyze data and interpret regulatory requirements.
7. Analyze and interpret regulatory guidance documents.
8. Develop and implement regulatory strategies.
9. Track changes to relevant regulations and legislative developments.
10. Stay up to date with current Good Clinical Practice (GCP).

According to JobzMall, the average salary range for a CTA/IND Regulatory Specialist in Warsaw, Poland is approximately 55,000 - 65,000 PLN per year. This range can vary based on experience and qualifications.

GlaxoSmithKline Pharmaceuticals Ltd. engages in the business of manufacturing, distributing and trading in pharmaceuticals. The company's product portfolio includes prescription medicines and vaccines. Its prescription medicines range across therapeutic areas such as anti-infective, dermatology, gynecology, diabetes, cardiovascular disease and respiratory diseases. The company also offers a range of vaccines, for the prevention of hepatitis A, hepatitis B, invasive disease caused by H, influenza, chickenpox, diphtheria, pertussis, tetanus, rotavirus, cervical cancer, streptococcus pneumonia and others.