Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Precision for Medicine is not your typical CRO. At Precision for Medicine we bring together new technologies, expertise and operational scale to help life sciences improve the speed, cost and success rate of bringing life‑changing therapies to patients. 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.

We are recruiting a Regulatory Manager / Senior Regulatory Manager to join our team. Candidates may be based in the UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.

The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. The role ensures timely preparation of well‑organized, quality regulatory submissions in compliance with applicable regulations and coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.

Responsibilities

• Provides regulatory guidance throughout the clinical development life cycle
• Compiles, coordinates and reviews applications to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications; provides strategic regulatory input as required
• Develops and/or reviews documents intended for submission to Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Acts as representative of Global Regulatory Affairs in project team meetings with external and internal customers
• Works within a project team and leads projects for the region or globally where necessary
• Oversees and coordinates Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintains project plans, trackers and regulatory intelligence tools, and keeps Regulatory Leadership updated
• Develops and mentors Regulatory Affairs Specialists and other operational staff as required
• Provides input into regulatory strategy and timeline development for new study opportunities; assists in establishing company standards to ensure the highest quality of submitted information
• Participates in maintaining and executing corporate quality initiatives across business units within clinical solutions
• Keeps abreast of and continuously expands knowledge of laws, regulations and guidelines governing drug development and approval
• Provides ICH GCP guidance, advice and training to internal and external clients
• Serves as representative of Global Regulatory Affairs at business development meetings

Qualifications – Minimum Required

• Bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline
• 5 years of regulatory experience for the Manager level (7 years for the Senior Manager level)
• Computer literacy (MS Office/Office 365)
• Fluency in English

Preferred

• Graduate or postgraduate degree
• Basic understanding of financial management

Other Required

Candidates must have regulatory affairs experience working for a Clinical Research Organisation and experience leading Clinical Submissions. They must have informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US). This includes, but is not limited to, submissions to Regulatory Authorities, INDs/CTAs and amendments, Scientific Advice Procedures, and post‑approval submissions.

• Ability to understand clinical and pre‑clinical study results to aid in regulatory positions and strategy
• Knowledge of clinical trials methodology, including a working knowledge of protocols and indications being studied
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
• Availability for domestic and international travel, including overnight stays

Competencies

• Strong interpersonal skills and proven ability to contribute to a team environment involving multifaceted research activities
• Demonstrates professionalism, punctuality, ability to deliver on commitments, and excellent customer interactions
• Ability to manage multiple and varied tasks in a fast‑moving environment, with good record‑keeping skills
• Exhibits high self‑motivation and works both independently and in a team environment
• Motivates other team members to meet timelines and project goals
• Adapts flexibly to work assignments and new learning
• Resolves project‑related problems and prioritizes workload to meet deadlines with minimal management support
• Focuses on continuous improvement, proactively improving processes and people effectiveness
• Collects data of consistently high standard
• Communicates effectively in English, both verbally and in written form
• Conducts formal presentations to a wide variety of audiences with high proficiency

About Us

We invite you to learn more about our growing organization, which serves clients researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every day. Your ideas will be valued and nurtured, impacting positive change for the company.

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 or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Please note that offers of employment have not been extended by our company and any offers received are likely fraudulent.