Regulatory Affairs Director Leader
2 days ago
We are seeking a highly motivated and experienced Global Head of Regulatory Affairs to join our team at Northreach. As a key member of our organization, you will play a pivotal role in shaping the future of regulatory affairs and driving business growth.
Responsibilities- Develop and implement global regulatory strategies that ensure compliance with local and international regulations.
- Provide strategic advice to leadership on best practices, recommend system improvements, and drive business growth.
- Act as a strategic partner to the business, supporting objectives and due diligence activities.
- Manage the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.) to health authorities such as MHRA, FDA, EMA, and others.
- Foster communication with regulatory bodies to ensure timely approvals.
- Collaborate with internal teams and external partners to align with regulatory strategies.
- Build and lead the regulatory team, fostering a culture of trust, communication, and high performance.
- Maintain up-to-date knowledge of global regulations and ensure effective knowledge sharing across the organization.
- Identify regulatory risks and develop mitigation strategies.
- Master's or doctoral degree in biology, chemistry, pharmacy, or related life sciences field.
The estimated annual salary for this position is $225,000-$275,000.
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