Global Regulatory Expert
Vor 2 Tagen
About Us:
We are committed to delivering high-quality products and services to our customers across Europe.
The Medicinal Product Specialist will be responsible for developing and implementing regulatory strategies to ensure the successful approval and launch of new products as well as improvement through new claims evaluation.
This role requires a deep understanding of regulatory requirements for medicinal products, strong strategic thinking, and excellent communication skills.
- Develop and implement regulatory strategies for new product developments, ensuring alignment with business goals and regulatory requirements.
- Provide expert regulatory advice and support to project teams throughout the product development lifecycle.
Key Responsibilities:
- Regulatory Strategy Development:
- Develop and implement regulatory strategies
- Provide expert regulatory advice and support
- Identify potential regulatory hurdles and develop mitigation plans
- Assess the impact of regulatory changes on new product developments
- Regulatory Submissions:
- Evaluate, compile, prepare, review, and submit regulatory documents
- Coordinate with cross-functional teams to gather necessary data and documentation
- New Claims Evaluation and Implementation:
- Evaluate new product claims to ensure they meet regulatory requirements
Qualifications:
- Bachelor's degree in a scientific discipline or related field. Advanced degree preferred.
- Minimum of 10 years of experience in regulatory affairs, preferably in the healthcare or pharmaceutical industry.
- Proven track record of successful medicinal product registrations and new product developments.
- Strong knowledge of regulatory requirements and guidelines.
What We Offer:
- Competitive salary and benefits package.
- Career growth and development opportunities.
- A collaborative and inclusive work environment.
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