Regulatory Affairs Director
5 days ago
At Northreach, we pride ourselves on connecting businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience, fostering equality, innovation, and professional growth.
We have partnered with an international pharmaceutical company dedicated to maintaining access to niche medicines. They are leaders in acquiring, integrating, and optimising medicines for small patient populations.
The company is seeking a highly skilled Regulatory Affairs Director to join their fast-growing dynamic team. This key role involves developing regulatory strategies across all phases of product development.
Key Responsibilities:- Developing and implementing innovative global regulatory strategies while ensuring compliance with local and international regulations.
- Partnering with the business as a strategic advisor to achieve company objectives, including due diligence activities.
- Overseeing the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, etc.) to health authorities like the MHRA, FDA, EMA, and others.
- Serving as the primary liaison with regulatory bodies, driving communications to maximise timely approvals.
- Fostering cross-functional communication with internal and external partners to ensure alignment with regulatory strategy.
- Leading and building a high-performing regulatory team to develop knowledge, skills, and capabilities to effectively deliver the business strategy.
- Maintaining contemporary knowledge of global regulations and ensuring effective knowledge sharing across the business.
- Identifying potential regulatory risks and developing mitigation strategies.
**Salary:** £80,000 - £110,000 per annum, depending on experience.
**Requirements:** Extensive experience in global regulatory affairs within the pharmaceutical, biotech, or medical device industry. In-depth knowledge of preparing and maintaining dossiers for clinical trials and marketing authorisations. Experience of seeking advice from and leading meetings with regulatory agencies. Strong leadership skills and ability to build a high-performing team.
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