Regulatory Associate Manager - Product Variations GlaxoSmithKline

Responsibilities
Independently and confidently executes agreed dossier strategy.

• Independently manages multiple Rx and/or Vx project assignments 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.
• May act as reviewer/approver for dossiers prepared by 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 (PSC, LOC, PO 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

• Bachelor s degree.( Chemistry, pharmacy or other related science or technical bachelor s degree.
• Working in complex environment within a scientific organizationbr>Minimum 3-8 years of experience
• Broad understanding of the pharmaceutical industry, drug development environment, and R&D 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.

Work Arrangement
This role is on-site in India. You will work closely with local and global colleagues and may join cross-site virtual meetings.

What to expect next
If you are ready to grow your regulatory career and help deliver meaningful patient impact, we want to hear from you. Please apply and tell us how your skills and experience match this role. If you need any adjustments during the recruitment process, please let our recruitment team know so we can support you.