Regulatory Affairs Director
3 weeks ago
Stirling Q&R is seeking a seasoned Senior Director of Regulatory Affairs to spearhead the regulatory strategy and operations for our esteemed client in the biotech industry.
Key Responsibilities- Develop and execute regulatory plans to support product development and market access for biopharmaceutical products.
- Lead a team of regulatory professionals to ensure timely and high-quality regulatory submissions to health authorities.
- Provide strategic guidance on regulatory requirements and compliance during research and development stages.
- Establish and maintain relationships with regulatory agencies and serve as the primary point of contact.
- Monitor and assess regulatory changes to provide strategic insights to the team and company leadership.
Requirements
Qualifications- Advanced degree in a relevant scientific field.
- 8-10 years of experience in regulatory affairs, with at least 5 years in a leadership role.
- Deep understanding of regulatory requirements for product development, submissions, and compliance protocols.
- Proven track record of successful submissions and approvals with health authorities.
- Strong leadership and team management skills.
- Excellent communication, negotiation, and organizational skills.
Benefits
- Private Health Insurance
- Pension Plan
- Work From Home
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