Are you passionate about regulatory affairs and eager to make a global impact? GlaxoSmithKline (GSK), a leading biopharma company, is seeking a talented Regulatory Specialist for Submission Delivery Excellence LCM to join their team in Bengaluru, India. This exciting role offers the opportunity to work on critical submission processes for pharmaceutical and vaccine products in the Rest of the World (ROW) markets, ensuring compliance and high-quality delivery. If you thrive in a dynamic, collaborative environment and are ready to contribute to GSK’s mission of uniting science, technology, and talent to get ahead of disease, this is the perfect opportunity for you.
Key Responsibilities
As a Regulatory Specialist, you will play a pivotal role in ensuring the timely and compliant delivery of regulatory submissions. Your responsibilities will include:
- Coordinating the delivery of assigned submissions to Project Leads, Senior Submission Coordinators, or equivalent stakeholders, ensuring adherence to agreed timelines and content quality for ROW markets.
- Managing maintenance activities for approved products, including product renewals, label harmonization, PBRER submissions, site registrations/renewals, tenders, variations, and PREPs.
- Following GSK’s standardized processes to achieve right-first-time delivery.
- Utilizing regulatory intelligence resources to ensure submission data packages meet requirements.
- Communicating regularly with line managers, technical leads, functional teams, and local operating companies (LOCs) to execute dossier strategies and escalate issues with business impact.
- Ensuring quality and compliance with regulatory guidelines, under management oversight.
- Managing multiple project assignments of varying complexity simultaneously.
- Demonstrating learning agility to understand internal and external regulatory environments.
- Building effective working relationships and organizational networks.
- Attending knowledge exchanges and training sessions to deepen expertise in regulatory affairs.
- Participating in process improvement initiatives to enhance efficiency.
Qualifications
To succeed in this role, you should have:
- A Bachelor’s degree in a biological or healthcare science field, or equivalent experience in regulatory affairs within a drug development environment.
- 1-3 years of relevant experience in the pharmaceutical industry or regulatory affairs.
- General understanding of the pharmaceutical industry, drug development, and R&D processes.
- Developing knowledge of regulations, guidelines, and policies related to pharmaceutical and vaccine product registration and manufacturing.
- Proficiency in Regulatory Information Management (RIM) systems or the ability to quickly learn them.
- Strong organizational skills, attention to detail, and a commitment to delivering high-quality work under tight regulatory deadlines.
- Excellent written and verbal communication skills for clear and concise information presentation.
- Ability to interpret and advise on guidelines for assigned submission types, leveraging recent GSK experience.
- Capability to build effective relationships and work collaboratively in a matrix environment.
- Flexibility to manage multiple projects and prioritize tasks effectively.
- A customer-focused, service-oriented mindset.
- Ability to utilize internal and external resources to address unique regulatory scenarios.
Benefits of Working at GSK
Joining GSK means being part of a global biopharma leader committed to improving the health of billions through innovative vaccines, specialty, and general medicines. Benefits include:
- A dynamic, inclusive workplace where you can thrive, grow, and feel valued.
- Opportunities to work on cutting-edge projects in infectious diseases, HIV, respiratory/immunology, and oncology.
- Access to continuous learning and professional development through knowledge exchanges and training.
- A collaborative environment that fosters innovation and teamwork.
- The chance to contribute to GSK’s mission of getting ahead of disease together.
How to Apply
