Description
Job Location: Great Britain, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Company Overview:
Precision for Medicine is not your typical CRO. At Precision for Medicine we 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 us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
Position Overview:
Due to growth, Precision for Medicine are seeking a Regulatory Manager to join our team. Candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.
Responsibilities:
- Provide regulatory strategy and development guidance for optimal conduct of clinical trials.
- Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.
- Compile, coordinate and review applications to Regulatory Authorities including CTA/INDs.
- Develops/reviews documents intended for submission to assure compliance with regulatory standards.
- Serve as representative of Global Regulatory Affairs at project team meetings.
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets.
- Maintenance of project plans, trackers and regulatory intelligence tools related to assigned responsibilities.
- Assist in development of Regulatory Affairs Specialists as required.
- Provide input into regulatory strategy development for new study opportunities.
- Participate in maintaining corporate quality initiatives across business units within clinical solutions.
Qualifications:
Minimum Required:
- Bachelor's degree or equivalent experience in a scientific or healthcare discipline.
- 5 years Regulatory experience required for Manager level; 7 years required for Senior Manager level.
- Computer literacy (MS Office/Office 365).
- Fluent in English.
Preferred:
- Graduate or postgraduate degree preferred.
Other Required:
- Candidates must have regulatory affairs experience working for a Clinical Research Organisation with experience leading Clinical Submissions.
- Informed knowledge of all aspects of drug development process including milestones specific knowledge of activities in at least one major region (EU/US).
- Ability to understand clinical/pre-clinical study results relevantly interpreting them towards regulatory positions/strategy.
Competencies:
- Strong interpersonal skills contributing effectively within team environments balancing multifaceted research demands.
- Professionalism evidenced by punctuality & commitment delivery understanding service culture positively interacting with customers/team members.
- Ability managing multiple varied tasks fast-moving environment good record keeping skills exhibiting high self-motivation working independently/team settings motivating others meet timelines/project goals flexible attitude work assignments/new learning resolving project-related problems prioritizing workload meeting deadlines little support management focusing continuous improvement making proactive assessments improving processes/effectiveness collecting high standard data communicating effectively English verbally/written conducting formal presentations diverse audiences colleagues investigative staff clients proficiently.
Equal Opportunity Employer Statement:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status other characteristics protected by law.
Privacy Notice Statement:
Any data provided as part application will be stored accordance Privacy Policy CA applicants please refer CA Privacy Notice.
Fraud Warning Statement:
It has come attention some individuals organizations reaching out job seekers posing potential employers presenting enticing employment offers emphasizing these offers not associated company may fraudulent nature noting organization extend job offer without prior communication recruiting team hiring managers formal interview process.
Application Process Information:
If you require reasonable accommodation complete any part application process limited ability unable access use online application process need alternative method applying contact Precision Medicine Group at .
Lifelancer Platform Information:
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