Compliance Analyst supporting the approval and licensing of alcoholic beverages globally. Involves regulatory tasks, compliance reviews, and organizational duties in a dynamic environment.
About the role
- Regulatory Affairs Professional managing submissions across US, EU, and RoW for pharmaceuticals. Ensuring compliance and coordinating with cross-functional teams for timely approvals.
Responsibilities
- Develop and manage regulatory submissions and documentation across US, EU, and RoW
- Plan and coordinate submission and roll-out of Sema NDAs and brand variations
- Create content plans for various submission types, including NDAs/MAAs, variations, and supplements
- Prepare country-specific Module 1 documents and regional submission components
- Ensure compliance with regulatory agency requirements and regional laws
Requirements
- Bachelor or Master of Science (life sciences) and/or relevant PhD
- 3-7 years of experience in regulatory affairs within pharmaceutical or biotechnology sectors
- Proven expertise in product registration and regulatory strategy
- Fluent in written and spoken English
Benefits
- Opportunities to learn and develop
- Health insurance
- Pension scheme
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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