
Global Regulatory Strategist
7 days ago
This role focuses on spearheading the development and implementation of global regulatory strategies to ensure timely product approvals and market access across multiple health authorities.
- The successful candidate will develop, implement, and manage global regulatory strategies to ensure timely product approvals and market access in various health authorities.
- Provide expert regulatory advice to senior management on evolving regulations and their impact on business goals.
- Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, and Marketing, to align regulatory activities with overall business objectives.
In addition, you will be responsible for preparing and submitting Controlled Correspondence, Pre-submission Meeting Requests, and Scientific Advice for global markets. Furthermore, you will evaluate pre-PIFs and provide regulatory submission requirements for US and EU, with extended submissions for other regions.
Required Skills and Qualifications- Proven expertise in developing and implementing global regulatory strategies.
- Strong knowledge of regulatory affairs principles, laws, and regulations in multiple regions.
- Excellent communication and collaboration skills to work effectively with cross-functional teams.
This position offers a unique opportunity to contribute to the success of our organization by shaping global regulatory strategies and ensuring timely product approvals and market access.
Additional ResponsibilitiesAs a Regulatory Affairs Manager, you will have the opportunity to work closely with various stakeholders to drive business growth and achieve regulatory compliance.
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