Biotech Regulatory Strategist
4 weeks ago
We are looking for a highly skilled Biotech Regulatory Strategist to join our team at Stirling Q&R. As a Senior Director of Regulatory Affairs, you will be responsible for leading the regulatory strategy and operations for our esteemed client in the biotech industry.
Key Responsibilities- Develop and implement regulatory strategies to support product development and market access for biopharmaceutical products.
- Lead a team of regulatory professionals to ensure the timely preparation and submission of high-quality regulatory documentation to health authorities, including INDs, BLAs, and MAAs.
- Advise cross-functional teams on regulatory requirements and provide guidance on compliance during research and development stages.
- Establish and maintain relationships with regulatory agencies and act as the primary point of contact during agency interactions.
- Monitor and assess changes in regulations and guidelines to provide strategic insights to the team and company leadership.
- Oversee the preparation for regulatory submissions and inspections, ensuring adherence to best practices.
- Mentor and develop regulatory staff, fostering a culture of excellence and accountability.
The ideal candidate will have a strong background in regulatory affairs and a minimum of 8 years of experience in the pharmaceutical or biotechnology industries, with at least 5 years in a leadership role.
Compensation Package- Competitive salary: $150,000 - $200,000 per year
- Private Health Insurance
- Pension Plan
- Work From Home
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