Regulatory Affairs Associate
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Key skills for this role
About the Role
NewBridge Pharmaceuticals seeks a Regulatory Affairs Associate to support implementation of regulatory strategy for pharmaceutical products in the MENA region. The role involves preparing dossiers, coordinating with regulatory teams, and ensuring compliance.
Key Skills for This Role
Responsibilities
- Liaise with Group Therapy Area to identify and provide regulatory guidance
- Apply regulatory expertise to prepare high quality documentation and assure compliance
- Coordinate with Regulatory Affairs Team Members regarding receipt, distribution and response to regulatory queries
- Assist in preparation of regulatory strategies and plans for product portfolios
- Build and assure dispatch of customized dossiers to markets
- Develop detailed understanding of regulatory guidelines and technical requirements in assigned markets
- Ensure business compliance and implementation of regulatory standards
- Maintain comprehensive records of communications, country requirements and regulatory status
- Regular follow up on progress of regulatory submissions with Access team
- Participate and/or lead cross functional project teams
Requirements
- Graduate with degree in Life Sciences
- Preferable with Masters in Life Sciences, MBA, etc.
- Minimum 2 years proven performance in regulatory executive role in MNC Pharmaceutical/healthcare company in MENA Region
Full Job Posting
Purpose of the Role
- Responsible for implementation of Regulatory Affairs Strategy
- Support Regional Regulatory Affairs Manager and team members
- Collaborate with Franchise Leads and external partners to achieve regulatory objectives
Required Competencies, Qualifications and Experience
- Graduate with degree in Life Sciences
- Preferable with Masters in Life Sciences, MBA, etc.
- Minimum 2 years proven performance in regulatory executive role in MNC Pharmaceutical/healthcare company in MENA Region
Regulatory Affairs
- Liaise with Group Therapy Area to identify and provide regulatory guidance
- Apply regulatory expertise to prepare high quality documentation
- Coordinate with Regulatory Affairs Team Members regarding regulatory queries
- Assist in preparation of regulatory strategies and plans
- Build and assure dispatch of customized dossiers to markets
- Develop detailed understanding of regulatory guidelines
- Ensure business compliance and implementation of regulatory standards
- Maintain comprehensive records of communications
- Regular follow up on progress of regulatory submissions
Project Management
- Ensure product strategies, submission and approval timelines are captured in systems
- Ensure notifications of regulatory changes communicated to stakeholders
- Participate and/or lead cross functional project teams
- Represent countries at relevant regulatory and project teams
- Contribute to development of filing and approval goals
- Lead and implement regulatory process improvement activities
Others
- Provide training to internal stakeholders and partners
- Expert knowledge in Regulatory Affairs for assigned product portfolio
- Support and collaborate with other Regulatory team colleagues and cross functionally
- Support Senior Director and Regulatory Affairs Manager to achieve goals
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