Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
About the role
- Expert in CMC Regulatory Strategy at Ipsen focusing on preparing regulatory strategies and compliance in pharmaceuticals. Collaborating with teams for effective CMC dossiers and monitoring submission timelines.
Responsibilities
- Responsible for preparing CMC regulatory strategies for assigned projects
- Contribute to the development of CMC regulatory dossiers aligned with defined roadmaps
- Anticipate any gaps in planned regulatory submissions and respond to requests for information
- Monitor identified risks in CMC-Regulatory assigned activities
- Participate in coordinating the CMC regulatory section preparation of briefing documents
- Deliver effective, timely and compliant CTA (IND, IMPD) and MAA modules 1, 2 & 3
- Collaborate with teams and Subject Matter Experts (SME)
- Ensure compliance with Ipsen group policies and procedures
- Liaise with SMEs for authoring Regulatory Response to Questions
Requirements
- Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science)
- Minimum 3 years direct experience in CMC regulatory R&D environment in pharmaceutical industry
- Previous experience in CMC regulatory field in a worldwide environment
- Previous technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions
- Understanding of Quality activities and assessment of cGMP compliance, site registration and licensing
- Ability to work in a cross-functional global environment and experience in stakeholders management
- Excellent written, verbal and interpersonal communication skills, highly organized
- Ability to handle multiple priorities and complex projects in a fast-paced environment
- Analytical mindset and excellent attention to detail
- Problem-solving skills
- Fluent English
- French preferred
Benefits
- Competitive salary
- Flexible working hours
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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