Senior Regulatory Specialist

Position Summary

You will lead regulatory CMC activities for Vx products in India. You will manage post-approval variations, site and supply changes, and responses to health authority questions. You will work closely with quality, manufacturing, supply and global regulatory colleagues. We value clear communication, attention to detail and collaborative problem solving. This role offers growth, visible impact on patient access, and the chance to unite science, technology and talent to get ahead of disease together.

Responsibilities

• Independently and confidently executes agreed dossier strategy.
• Independently manages multiple project simultaneously; assignments will range in complexity but more complex work is expected.
• Independently completes data assessment to ensure dossier is fit for purpose.
• Identifies risks associated with submission data and information packages.
• Escalates issues with line manager that have business impact.
• Serves as dossier reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems.
• Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff.
• Understands internal/external regulatory environment.
• Actively builds an organisational network (GSC, LOC, PO, team members and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
• Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.

Preferred Qualification

• Minimum 8-10 years of experience
• Broad understanding of the pharmaceutical industry, drug development environment, and RD processes and objectives.
• Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
• Ability to build effective working relationships and work in a matrix environment effectively
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.