Regulatory and Start Up Specialist New Remote, Singapore

Precisionscientia; Maryland; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company in precision medicine is seeking a Regulatory and Start-Up Specialist to join their team in Singapore. The role involves ensuring compliance with regulations, managing site activation, and supporting clinical trial activities. Ideal candidates will have a background in life sciences and experience in regulatory processes. Strong communication and organizational skills are essential.

Qualifications

• At least 1 year of experience in CRO or pharmaceutical/biotech industries.
• Bachelor’s degree in life sciences or related field.

Responsibilities

• Ensure timely delivery of site activation readiness.
• Prepare Clinical Trial Application Forms and submission dossiers.
• Engage with Competent Authorities and Ethics Committees.

Skills

Communication

Organizational Skills

Fluency in English

Education

Bachelor’s degree in life sciences

RN qualification

Tools

Computerized systems

Spreadsheets

Email

Job description

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal passion for rare diseases and oncology, among other therapeutic areas.

Job Opportunity: Regulatory and Start-Up Specialist in Singapore

As our company continues to grow, we are seeking a Regulatory and Start-Up Specialist to join our expanding team in Singapore.

Essential Functions

1. Ensure timely and quality delivery of site activation readiness within assigned countries/sites, proactively managing risks.
2. Prepare Clinical Trial Application Forms and submission dossiers for authorities and ethics committees, ensuring compliance with local and international regulations, SOPs, and ICH-GCP principles.
3. Engage with Competent Authorities and Ethics Committees, managing responses and updates.
4. Maintain project plans, trackers, and regulatory intelligence tools, and support start-up plans, IMP release, and document review.
5. Coordinate with site CRAs to ensure alignment and manage essential documents collection for site activation and IMP release.
6. Customize and coordinate translation of patient information sheets and consent forms.
7. Maintain communication with cross-functional teams regarding project status and deliverables.
8. Act as SME for critical path data points related to site activation, including CA, IRB/EC timelines, contracts, and budgets.
9. Support negotiation of study budgets and investigator contracts as needed.
10. Participate in feasibility assessments and site outreach.
11. Stay updated on local clinical trial laws and regulations, ensuring compliance.
12. Maintain audit/inspection readiness and document filing as per TMF plans.
13. Support clinical team activities such as Pre-Study Site Visits.

Candidate Profile

Required:

• Bachelor’s degree in life sciences or related field, or RN qualification, with relevant experience.
• At least 1 year of experience as a Regulatory or Start-Up Specialist in CRO or pharmaceutical/biotech industries.

Additional Skills:

• Strong communication and organizational skills.
• Proficiency with computerized systems, spreadsheets, and email.
• Fluency in English.

Preferred:

• Experience with regulatory and site start-up processes.
• Knowledge of milestone tracking tools.
• Ability to prioritize and meet deadlines.
• Advanced degrees or certifications in medical or regulatory sciences are a plus.

Our Commitment

We value our employees and their contributions, fostering an environment of appreciation and positive impact. We adhere to strict privacy policies and are an Equal Opportunity Employer. For accommodations or concerns about fraudulent recruitment practices, please contact us directly.