Regulatory Affairs Strategist
Vor 2 Tagen
About Us:
We are a rapidly expanding consumer healthcare business with a strong European presence. Our commitment is to delivering high-quality products and exceptional value to our customers.
The Regulatory Affairs Strategist 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.
- Formulate comprehensive regulatory strategies for new product developments, ensuring alignment with business goals and regulatory requirements.
- Evaluate, compile, prepare, review, and submit regulatory documents for Marketing Authorization Applications (MAA) to obtain approval for marketing new products in different regions.
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
- Cross-Functional Collaboration:
- Work closely with R&D, Quality Assurance, Medical Affairs, and Marketing teams
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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