About Company
At GSK, our purpose is to unite science, technology and talent to get ahead of disease together. We are a global biopharma company, with a special focus on the science of the immune system, human genetics, and advanced technologies. We are committed to making a difference in the lives of millions by developing innovative medicines, vaccines, and specialty products. Our culture is one of collaboration, integrity, and relentless pursuit of scientific excellence, empowering our people to bring their best and make a significant impact on global health. Join a team where your contributions matter and where you can grow your career within a truly global organization dedicated to improving human health worldwide. GSK is an equal opportunity employer committed to diversity and inclusion.
Job Description
Are you a highly organized, detail-oriented professional with a passion for compliance and a desire to contribute to groundbreaking pharmaceutical developments? GSK is seeking a proactive Regulatory Affairs Assistant to join our dedicated team in Caloosa, Bonita Springs, Florida. This is an exceptional opportunity for an ‘Immediate Start’ candidate eager to dive into the dynamic world of pharmaceutical regulatory affairs, ensuring our innovative products meet stringent global standards.
In this pivotal support role, you will be instrumental in the preparation, submission, and maintenance of regulatory documentation for a diverse portfolio of medicines, vaccines, and specialty healthcare products. You will work closely with experienced Regulatory Affairs Managers, scientists, and cross-functional teams, gaining invaluable exposure to the entire product lifecycle from development to post-market surveillance. Your keen eye for detail and commitment to accuracy will be critical in navigating complex regulatory landscapes and ensuring timely submissions. This role is not just about paperwork; it’s about being at the forefront of bringing life-changing treatments to patients worldwide, ensuring they are safe, effective, and compliant with all regulatory requirements. If you thrive in a fast-paced environment and are ready to make an immediate impact within a world-leading biopharma company, we encourage you to apply. This position offers a fantastic pathway for career progression within regulatory affairs and the broader pharmaceutical industry, supported by GSK’s commitment to employee development and a culture of continuous learning.
Key Responsibilities
- Assist in the preparation, compilation, and submission of regulatory documents (e.g., dossiers, amendments, renewals) to global health authorities.
- Maintain and update regulatory databases and tracking systems with accuracy and attention to detail.
- Conduct quality control checks on regulatory submissions to ensure compliance with company standards and regulatory guidelines.
- Coordinate with cross-functional teams (e.g., R&D, Manufacturing, Marketing) to gather necessary documentation for submissions.
- Research and interpret regulatory guidelines and requirements relevant to product development and lifecycle management.
- Support the management of regulatory archives, ensuring all documentation is organized and readily accessible.
- Prepare reports and presentations on regulatory activities and project status as required.
- Assist with regulatory intelligence gathering, staying updated on changes in global regulations.
- Facilitate communication between regulatory bodies and internal teams as needed.
Required Skills
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences) or related field.
- Exceptional organizational skills and a meticulous attention to detail.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Ability to manage multiple tasks, prioritize effectively, and meet deadlines in a fast-paced environment.
- Demonstrated ability to work both independently and collaboratively within a team setting.
Preferred Qualifications
- Previous internship or entry-level experience in regulatory affairs, quality assurance, or a related field within the pharmaceutical or healthcare industry.
- Familiarity with regulatory frameworks such as FDA, EMA, or other international guidelines.
- Experience with electronic document management systems (EDMS) or regulatory submission software.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company matching.
- Generous paid time off, including vacation, sick leave, and holidays.
- Professional development and career advancement opportunities.
- Tuition reimbursement program.
- Employee assistance programs and wellness initiatives.
- Opportunities to work on impactful projects that improve global health.
- Collaborative and inclusive work environment.
How to Apply
To apply for this exciting opportunity and become a part of the GSK team, please click on the application link below. You will be redirected to our careers portal where you can submit your detailed resume and cover letter. We look forward to reviewing your application!