GSK Hiring Chemistry Graduates for Regulatory Affairs Role | Apply Now
The GSK Regulatory Affairs Job for a Senior Regulatory Specialist is open to experienced professionals in Bengaluru, India. This full-time position offers a hybrid work model and aims to enhance the lives of billions through innovative healthcare solutions. Applications are encouraged before the deadline.
About GSK:
GSK is a global healthcare company that unites science, technology, and talent to advance healthcare and improve lives. With a commitment to research and development, GSK focuses on discovering and delivering vaccines and medicines that can positively impact the health of billions of people worldwide. The organization fosters an inclusive environment where outstanding individuals collaborate to create significant health advancements.
Job Details:
- Location: Bengaluru, India
- Category: Regulatory
- Job ID: 449562
- Work Model: Hybrid (Remote & On-site)
GSK Regulatory Affairs Job Description
The Senior Regulatory Specialist will represent the CMC Delivery team on Regulatory Networks and Matrix Teams, providing guidance to various stakeholders, including Pharma Supply Chain, Commercial, Quality Assurance, and Contract Manufacturing Organizations. This regulatory specialist role requires a comprehensive understanding of submission requirements for multiple countries and an ability to work effectively in a matrix environment, ensuring timely delivery of regulatory activities across various Vx projects.
Key Responsibilities:
- Independently manage multiple Vx CMC regulatory submission assignments simultaneously, handling assignments of varying complexity.
- Execute agreed dossier strategy confidently and independently.
- Complete data assessments to ensure dossiers are fit for purpose.
- Identify risks associated with submission data and information packages.
- Escalate issues with the line manager that have business impact.
- Act as reviewer/approver for dossiers prepared by peers and identify improvement opportunities for Regulatory processes, policies, and systems.
- Understand regulations, guidelines, and procedures relating to registration and manufacturing of pharmaceutical products.
- Build an organizational network and promote knowledge sharing across GSK.
Senior Regulatory Specialist Eligibility Criteria
- Minimum 3-8 years of experience in a complex scientific environment.
- Bachelor’s degree in Chemistry, Pharmacy, or a related science or technical field.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes.
- Experience with Global/EMAP Regulatory submissions and knowledge of regulatory agency guidelines.
- Excellent organizational skills and attention to detail.
- Strong written and verbal communication skills.
- Ability to interpret and advise on global guidelines and requirements.
- Capability to build effective working relationships in a matrix environment.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
This GSK Regulatory Affairs Job for the role of Senior Regulatory Specialist is a significant step for qualified candidates looking to make a difference in global healthcare. Interested individuals are encouraged to apply at the earliest to be part of this impactful journey.
