Specialist in Regulatory Compliance supporting sustainability initiatives at FERI Group. Responsible for analysis, reporting, and development of sustainable finance products.
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
Graduate role in Internal Audit & GRC services at PwC, supporting organisations in regulatory compliance and risk management. Assisting with data analysis, process mapping, and client engagements.
Export Control / Trade Compliance Officer ensuring customs compliance with Australian and U.S. laws. Advising on trade compliance issues and solutions across various projects and teams.
Vice President of Compliance & Regulatory Affairs leading compliance strategy for Cotulla Education. Supporting growth and regulatory compliance across multiple institutions and campuses.
Compliance Officer with focus on AML and compliance tasks at Schulz & Cie. Consulting. Conducting audits, transaction monitoring, and managing regulatory issues in financial services.
Lead compliance and risk management at Thndr Securities Brokerage, ensuring regulatory adherence and overseeing compliance operations. Collaborate with teams to mitigate risks and educate on compliance programs.
Key contributor in Integrated Resource Planning at Duke Energy. Prepare executives for regulatory testimonies on future energy demands and regulatory compliance.
CMC Regulatory professional managing regulatory compliance activities for veterinary biological products at Zoetis. Supporting development and inspections for the new GMS Atlanta site with FDA and USDA expectations.
Compliance Associate supporting Fidelity's Asset Management Compliance operations through various responsibilities in financial services. Engaging in problem - solving and maintaining organizational compliance while collaborating with multiple departments.
CMC Regulatory professional at Zoetis preparing regulatory documentation and ensuring compliance with FDA and USDA regulations. Managing facility documents and participating in cross - functional project improvements.