Life Science Job at Precision for Medicine | Apply Now
Life science job opportunities are expanding globally, and this exciting opening at Precision for Medicine offers professionals a chance to work at the forefront of clinical research. If you’re looking for a regulatory specialist job in a dynamic CRO environment, this role in Hong Kong could be your next big career move in the life sciences industry.
- Job Position:Â Regulatory and Site Start Up Specialist.
- Location: Hong Kong
About the Organisation
Life science job opportunities at Precision for Medicine stand out due to its innovative approach in the CRO space. Precision for Medicine is not your typical CRO. At Precision for Medicine they have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets them apart is the way they integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. They have a strong focus on Oncology and Rare Disease.
Job Description
Life science job role at Precision for Medicine involves regulatory and site start-up activities. The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation.
Qualifications
Life science job requirements for this regulatory specialist job include:
Requirement
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline).
- 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- Strong communication and organizational skills are essential.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English and for non-English speaking countries the local language of country where position based.
Preferred
- Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
- Experience using milestone tracking tools/systems.
- Ability to prioritize workload to meet deadlines.
- Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science
Key Responsibilities
Life science job responsibilities in this regulatory specialist job include:
- Manage site activation readiness, ensuring timelines and quality standards are met.
- Prepare and submit clinical trial applications to CA, EC, and IRB as per regulations.
- Handle communication with regulatory authorities and ethics committees.
- Maintain project trackers, regulatory documents, and submission updates.
- Review and manage essential documents for site activation.
- Support budget negotiations and site contract processes.
- Collaborate with cross-functional teams for smooth study start-up.
- Ensure compliance with local and international clinical trial regulations.
- Maintain audit readiness and support process improvements.
