Regulatory Specialist Jobs at Precision Medicine Group, China | Life Sciences | Apply Now
Are you ready to take the next step in your career with a role that challenges and inspires? Dive into the world of Regulatory Specialist Jobs at Precision Medicine Group in Shanghai, where innovation meets opportunity. This position offers the chance to work at the forefront of regulatory affairs, ensuring compliance and contributing to life-changing clinical trials.
- Job Position: Regulatory and Site Start Up Specialist
- Location: Shanghai, Shanghai, China
About The Company
Precision Medicine Group is a leading Contract Research Organization (CRO) that integrates innovative technologies and scientific expertise to enhance the efficiency of clinical trials. With a strong focus on oncology and rare diseases, the organization aims to improve the speed and success rate of bringing life-changing therapies to patients. Precision Medicine Group operates globally, providing comprehensive solutions for the life sciences industry.
Job Description
The Regulatory and Site Start Up Specialist (RSS) is responsible for overseeing regulatory and site start-up activities. This includes managing clinical trial submissions to Competent Authorities and Ethics Committees, reviewing Informed Consent Forms, and ensuring compliance with local and international regulations. The RSS will act as a Subject Matter Expert, supporting site start-up activities and contributing to the development of country-specific tools and guidance documents.
Regulatory Specialist Jobs – Key Responsibilities
- Ensure timely and quality delivery of site activation readiness.
- Prepare Clinical Trial Application Forms and submission dossiers for regulatory approvals.
- Interact with Competent Authorities and Ethics Committees for study purposes.
- Provide updates on submissions to relevant project leads.
- Maintain project plans and regulatory intelligence tools.
- Develop study-specific start-up plans and document review criteria.
- Collaborate with site CRAs to ensure effective communication.
- Manage collection of essential documents for site activation.
Eligibility Criteria Required For Regulatory Specialist Jobs
- Bachelor’s degree in life sciences or related field, or equivalent experience.
- Minimum of 1 year experience as a Regulatory or Site Start Up Specialist.
- Strong communication and organizational skills.
- Proficiency in electronic information systems and software.
- Fluency in English and local language, if applicable.
Required Skills
- Experience in regulatory and site start-up processes.
- Ability to prioritize tasks and meet deadlines.
- Familiarity with milestone tracking tools.
- Advanced degree in medical or life sciences is preferred.
In conclusion, Regulatory Specialist Jobs at Precision Medicine Group in Shanghai offer a unique opportunity to make a significant impact in the life sciences sector. Don’t miss your chance to be part of a team that is transforming healthcare and improving patient outcomes worldwide. Apply today and take the first step towards a rewarding career.
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