Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Senior Manager overseeing regulatory asset management and project delivery in a global biopharma company. Leading cross-functional collaboration to ensure oversight and compliance with regulatory strategies.
Responsibilities
- Partner with GRL and Regulatory Matrix Teams and Early/Medicine Development Teams.
- Create and manage integrated regulatory plans.
- Ensure the team is on track to deliver per the Regulatory strategy.
- Collaborate across the R&D matrix for project management and submission oversight.
- Facilitate submission delivery expectations.
Requirements
- Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment.
- Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Strong project management expertise in the pharmaceutical industry or in a regulatory environment.
- Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.
- Experience with project management and resource management systems, tools, & reporting features.
Benefits
- Healthcare and wellbeing programmes
- Pension plan membership
- Shares and savings programme
- Annual bonus based on company performance
- Flexible working hours
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