Global Life Science Hub is partnering with an innovative pharmaceutical company in their search for a Regulatory Specialist. This company is dedicated to improving the quality of life for patients around the world by developing innovative and life-saving therapeutics.
The Regulatory Specialist will play a crucial role in ensuring compliance with regulatory requirements throughout the drug development process. The successful candidate will collaborate closely with cross-functional teams to provide regulatory guidance and expertise.
Responsibilities:
- Prepare and submit regulatory filings to health authorities, including INDs, NDAs, and other regulatory dossiers.
- Review clinical trial protocols, study reports, and other documentation to ensure compliance with regulatory requirements.
- Advise on regulatory strategies and identify potential regulatory risks and mitigation strategies.
- Stay current with changes in regulatory guidelines and requirements.
- Collaborate with cross-functional teams to ensure alignment on regulatory timelines and deliverables.
- Participate in regulatory agency meetings and communicate with health authorities as needed.
- Provide training and guidance to internal stakeholders on regulatory requirements and processes.
Requirements:
- Bachelor's degree in a scientific discipline; advanced degree is preferred.
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong knowledge of regulatory guidelines and requirements, including FDA regulations.
- Experience with regulatory submissions and interactions with health authorities.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented with strong organizational and project management skills.
Apply:
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com
United States
