GSK Hiring Regulatory Affairs Specialist II Submission Delivery
Location: Bangalore, India (Luxor North Tower)
Experience: 1 to 6 Years
Salary Range: ₹5 – ₹11 LPA
Qualification: B.Pharm, M.Pharm, MSc, M.Tech or related field
Job Type: Full-Time | Verified Job
If you’re a skilled regulatory professional looking to grow your career with a global pharmaceutical leader, this opportunity from GSK (GlaxoSmithKline) is not to be missed. The company is inviting applications for the Regulatory Specialist II – Submission Delivery role at its Bangalore office. This position offers a dynamic work environment, access to international regulatory projects, and a chance to contribute to life-changing medical innovations. GSK Hiring Regulatory Affairs Specialist II
About GSK
GlaxoSmithKline (GSK) is a world-renowned biopharmaceutical company committed to uniting science, technology, and talent to fight diseases and improve global health outcomes. With a diverse portfolio of specialty medicines, vaccines, and general pharmaceuticals, GSK continues to lead innovation in infectious diseases, oncology, immunology, and respiratory conditions.
GSK places a strong emphasis on employee well-being and career development, encouraging a workplace culture built on integrity, transparency, respect, and a patient-first mindset. GSK Hiring Regulatory Affairs Specialist II
Position Overview: Regulatory Specialist II – Submission Delivery
This role is critical to ensuring that regulatory submissions are completed accurately, efficiently, and in line with both global regulatory requirements and internal company standards. As a Regulatory Specialist II, you will work closely with document authors, project managers, and submission teams to facilitate successful delivery of complex regulatory submission packages.
This is an ideal role for candidates with a background in pharmacy or life sciences who have prior experience with electronic submissions and a desire to work in a fast-paced, compliance-driven environment. GSK Hiring Regulatory Affairs Specialist II
Key Responsibilities
- Document Support: Guide and assist scientific authors in preparing submission content using GSK’s document management and submission systems.
- Compliance Management: Ensure all documents meet internal quality standards and adhere to current Regulatory Authority (RA) guidelines.
- Publishing Expertise: Lead or contribute to the development of publishing best practices to enhance the submission process and reduce turnaround times.
- Submission Execution: Independently handle complex submission packages including initial filings, amendments, renewals, and variations.
- Quality Review: Perform verification and quality checks to ensure submission readiness and regulatory compliance.
- Process Support: Participate in submission review meetings and contribute to improvements in internal regulatory workflows.
- GSK Hiring Regulatory Affairs Specialist II
Candidate Profile
Required Qualifications:
- Experience: Minimum 1 year and up to 6 years in regulatory affairs, specifically in electronic submissions for pharma or biotech companies.
- Education: Degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or other relevant scientific fields.
- Skills:
- Proficiency in MS Word, Excel, Adobe PDF, SharePoint, and document management systems.
- Strong organizational and prioritization skills to meet regulatory deadlines.
- Attention to detail, ensuring regulatory documents are complete, accurate, and compliant.
Preferred Qualifications:
- A Master’s degree (M.Pharm, M.Tech, MSc, or equivalent) in a related field.
- Experience working with global regulatory authorities (e.g., FDA, EMA).
- Familiarity with ICH, eCTD, and global submission formats.
- Strong verbal and written communication skills, with the ability to collaborate across cross-functional teams.
- Prior experience in a regulated environment, preferably in pharmaceutical research and development or drug approval lifecycle.
Why Join GSK?
1. Culture of Innovation
At GSK, you’ll be part of a forward-thinking team dedicated to bringing new therapies to market. You’ll work with cutting-edge technology and experienced professionals in regulatory affairs and drug development.
2. Career Advancement
GSK promotes continuous learning and provides access to global training programs and leadership opportunities. Employees are encouraged to build their capabilities and grow within the organization.
3. Employee-Centric Policies
From flexible work arrangements to comprehensive health insurance and wellness programs, GSK prioritizes employee work-life balance and mental well-being.
4. Global Impact
Your work will contribute directly to the development and approval of medicines that improve the lives of millions of patients across the world. This is your chance to make a real difference in public health.
GSK Hiring Regulatory Affairs Specialist II
Application Process
Interested candidates can apply directly through GSK’s official careers portal. Shortlisted applicants will be contacted for the next stages of the selection process, which may include an online assessment and virtual/in-person interviews.
Make sure to prepare a well-structured resume highlighting your experience in regulatory submissions, technical skills, and educational qualifications. Demonstrating an understanding of regulatory processes and submission tools will give you an added advantage. GSK Hiring Regulatory Affairs Specialist II
Additional Pharma Job Opportunities
If you’re exploring similar roles in regulatory affairs or related departments, consider checking openings at:
- Damaira Pharma – Hiring across Regulatory Affairs, Production, Quality Control (QC), Microbiology, and Business Development.
- Axis Clinicals – Medical Writing and Pharmacokinetic Studies (for freshers).
- Merck – Business Executive roles for Life Sciences graduates.
Stay updated with platforms like Pharmabharat for real-time job alerts and verified listings from India’s top pharmaceutical employers. GSK Hiring Regulatory Affairs Specialist II
Final Thoughts
The Regulatory Specialist II – Submission Delivery role at GSK is a valuable opportunity for professionals eager to expand their expertise in regulatory operations and contribute to impactful healthcare innovations. If you meet the qualifications and are ready to take your career to the next level in a globally respected pharmaceutical company, apply now and become part of GSK’s mission to help people do more, feel better, and live longer. GSK Hiring Regulatory Affairs Specialist II
