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Senior Regulatory and Start Up Specialist, Chelmsford
Precision for Medicine is not your typical CRO. We leverage new technologies, expertise, and operational scale to improve the speed, cost, and success rate of bringing therapies to patients. Our strength lies in integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and data sciences.
We are hiring a Senior Regulatory and Start Up Specialist for our UK team. This position can be fully home-based.
Key responsibilities include:
* Ensuring timely and quality site activation readiness, identifying and mitigating risks.
* Preparing Clinical Trial Application Forms and submission dossiers for regulatory authorities and ethics committees, ensuring compliance with local and international regulations.
* Communicating with regulatory bodies and handling responses.
* Providing updates on submissions to project teams.
* Maintaining project plans, trackers, and regulatory intelligence tools.
* Supporting start-up plans, IMP release, and essential document review.
* Partnering with CRAs to ensure site collaboration.
* Managing essential documents for site activation and IMP release.
* Customizing patient information and consent forms.
* Coordinating translations of submission documents.
* Communicating with cross-functional teams about project status.
* Acting as SME for critical site activation data points.
* Supporting budget negotiations and investigator contracts as needed.
* Staying updated on local clinical trial laws and regulations.
* Ensuring audit/inspection readiness and proper document filing.
* Supporting pre-study site visits and feasibility assessments.
* Developing start-up process flows and training sessions.
* Mentoring staff on local regulations and procedures.
* Interacting with clients for updates and proposal activities.
Qualifications:
* Bachelor’s degree in life sciences, healthcare, or equivalent; RN or similar qualification.
* At least 3.5 years of experience as a Regulatory or Start-Up Specialist in CRO or pharma/biotech industries.
Additional requirements:
* Excellent communication and organizational skills.
* Proficiency with electronic systems, spreadsheets, and email.
* Fluency in English.
* Ability to prioritize and meet deadlines.
Preferred qualifications:
* Experience with UK regulatory and site start-up processes.
* Knowledge of milestone tracking tools.
* Experience mentoring junior staff.
* Advanced degrees or certifications (MD, PhD, PharmD, RAC, etc.).
* Knowledge of GCP/ICH guidelines.
* Strong attention to detail, organizational skills, and ability to work independently.
* Effective communication skills, both written and spoken.
* Flexibility and willingness to travel occasionally.
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We adhere to privacy policies and are an Equal Opportunity Employer. For accommodations or concerns about application fraud, please contact us at [email].
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