Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Leads vaccine development projects in CMC regulatory affairs to impact global health at GSK. Collaborates with teams to drive strategic decision-making and ensure successful project delivery.
Responsibilities
- Lead and oversee the development and execution of Vaccine CMC Regulatory strategies, ensuring alignment with GSK’s goals and regulatory requirements.
- Establish and direct appropriate agency communications including End of Phase 2, Pre BLA, Scientific advice, and ad-hoc product specific agency dialogue.
- Ensure risk assessments are conducted, and appropriate mitigation and treatment plans are defined for product developments.
- Provide appropriate GSK representation and input to product specific inspections for CMC aspects to secure approvals of new products and ensure continuous improvement.
- Direct global teams providing the primary interface with GSK global development products including in licensed assets.
- Manage direct agency interface for CMC product specific aspects for all GSK development and in-licensed assets.
- Proactively manage budget and resource requirements for the department.
- Liaise with the heads of CMC Regulatory Development Projects across modalities to drive aligned approaches for developments and filings.
Requirements
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- Extensive experience in vaccine physical product development, CMC regulatory affairs, or related areas.
- Extensive expertise of diverse market environments and requirements.
- Proven ability to assimilate new and emerging requirements and establish optimized approach in global context.
- Strong understanding of CMC regulatory requirements and processes for vaccine development.
- Extensive development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies.
- Experience managing teams and budgets effectively.
- Excellent communication and interpersonal skills, with the ability to influence and collaborate across diverse teams.
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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