Managing Director overseeing strategic development of technology solutions for Fixed Income, Equities and Compliance at TIAA. Ensuring technological infrastructure supports trading operations and regulatory compliance.
About the role
- Regulatory Submission Lead responsible for supporting regulatory submissions and collaboration with global teams. Focused on compliance with health authority regulations and GSK policies in healthcare and biological science.
Responsibilities
- Independently deliver assigned submissions according to agreed dossier strategy
- Collaborate with functional teams (CMC, Clinical, Nonclinical, etc.) and LOC contacts to ensure adherence to timelines
- Oversee multiple simultaneous project assignments (e.g., CMC and therapeutic Variations, PBRER, Renewals, Site Registrations/Site Renewals)
- Manage complex regulatory registration requirements from agencies, manufacturing sites or third-party providers
- Prepare, coordinate and ensure timely delivery of documents requested by health authorities
- Engage cross-functionally and with senior process-development teams to provide regulatory advice
- Provide training, consultation and tailored solutions within and beyond the department
- Maintain alignment with regulatory requirements, legislation and guidelines for EU, US and ROW markets
- Conduct scenario planning for multiple regulatory strategies and recommend delivery approaches
Requirements
- Bachelor’s degree or higher in biological or healthcare science
- 5 years of experience with strong understanding of the industry, drug development and R&D processes
- In-depth knowledge of regulations, guidelines and policies for pharmaceutical and vaccine registration and manufacturing
- Proficient in Veeva Vault for submission deliverables
- Excellent organizational, communication and interpersonal skills; able to deliver high-quality results under tight deadlines
- Skilled at interpreting global regulatory requirements and providing expert guidance informed by recent GSK experience
- Adaptable and proactive in managing workload, priorities and timelines within a matrix environment
- Proven ability to manage multiple projects concurrently and build strong internal stakeholder relationships.
Benefits
- Health insurance
- Retirement plans
- Flexible work arrangements
- Professional development
- Bonuses
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