Healthcare Job at GSK: Drive Global Regulatory Submissions – Apply Now!
GSK is offering an exciting healthcare job opportunity for professionals looking to grow in Regulatory Affairs. The role of Regulatory Specialist, Submission Delivery Excellence, involves working with global submission teams to ensure high-quality regulatory submissions, making it an excellent choice for candidates exploring GSK careers, jobs in Bangalore, or jobs in Poland within the pharmaceutical industry.
Job Details:
- Job Position: Regulatory Specialist, Submission Delivery Excellence
- Category: Regulatory
- Locations: Poznan Grunwaldzka, Poland | Bengaluru Luxor North Tower
- Job ID: 434141
About the Company:
GSK is a global biopharmaceutical organization dedicated to advancing healthcare through science and innovation. Known for strong research, manufacturing, and regulatory practices, GSK offers diverse healthcare job opportunities worldwide and is a preferred employer for professionals exploring long-term GSK careers.
Qualifications:
- Degree in healthcare, or extensive experience in Regulatory Affairs.
- Understanding of pharmaceutical industry R&D processes and objectives.
- Strong ability to interpret and apply regulations.
- Effective communication and stakeholder management skills in a matrix environment.
- Flexibility to manage changing priorities and timelines.
- Strong organizational skills, attention to detail, and commitment to quality output.
- Ability to proactively identify risks and ensure transparency of submission progress.
- Capability to lead or co-lead multidisciplinary regulatory meetings.
Job Description:
This healthcare job at GSK involves close collaboration with global submission teams and Local Operating Company regulatory contacts to deliver end-to-end submissions within agreed timelines. The role ensures compliance with Regulatory Authority regulations and GSK SOPs, supporting the company’s global portfolio and strengthening career growth within GSK. The position provides valuable exposure to international regulatory processes and cross-functional collaboration for professionals pursuing advanced healthcare job roles.
Key Responsibilities:
- Deliver marketing applications and lifecycle maintenance submissions, including product renewals and site registrations/renewals/variation submissions, within agreed timelines and regulatory guidelines.
- Coordinate MSR activities for various submission types while executing agreed dossier strategies.
- Manage end-to-end coordination, preparation, and delivery of regulatory registration samples in partnership with manufacturing sites and third-party providers.
- Identify and escalate submission-related risks with potential business impact.
- Apply regulatory guidelines, procedures, and policies to support efficient submission delivery.
- Participate in continuous process improvement initiatives.
- Support regulatory authority submissions, including renewals, variations, and PBRER submissions.
- Mentor and train team members as required.
