Senior Regulatory Specialist GlaxoSmithKline

Position Summary:
This role is an exciting opportunity to make a meaningful impact in Regulatory Affairs of biopharmaceutical asset/s. As a Senior Regulatory Specialist, you will play a key role in delivering regulatory submissions and ensuring compliance with evolving global standards. You ll collaborate with cross-functional teams and a wide range of stakeholders from all over the world to deliver high-quality CMC dossiers.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Independently and confidently executes agreed dossier strategy.
• Minimum of 3 years of experience in CMC
• Bachelor s degree in Chemistry, pharmacy or other related science or technical bachelor s degree.
• Independently manages multiple BioPharm 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 organizational network (GSC, 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
If you have the following characteristics, it would be a plus:

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Global Regulatory submission experience - Knowledge of regulatory agency guidelines
• Excellent organizational 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

Position Summary:
This role is an exciting opportunity to make a meaningful impact in Regulatory Affairs of biopharmaceutical asset/s. As a Senior Regulatory Specialist, you will play a key role in delivering regulatory submissions and ensuring compliance with evolving global standards. You ll collaborate with cross-functional teams and a wide range of stakeholders from all over the world to deliver high-quality CMC dossiers.

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Independently and confidently executes agreed dossier strategy.
• Minimum of 3 years of experience in CMC
• Bachelor s degree in Chemistry, pharmacy or other related science or technical bachelor s degree.
• Independently manages multiple BioPharm 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 organizational network (GSC, 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
If you have the following characteristics, it would be a plus:

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Global Regulatory submission experience - Knowledge of regulatory agency guidelines
• Excellent organizational 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