Regulatory Manager / Senior Regulatory Manager

About Precision for Medicine 👨‍⚕️

Precision for Medicine (CRO) is searching for a Regulatory Manager or Senior Regulatory Manager to join our team! This role offers the flexibility of remote work across several European countries.

The Role 💼

As a Regulatory Manager/Senior Regulatory Manager, you'll be a key player in guiding the regulatory strategy and development of our clinical trials. Your expertise will be essential in ensuring timely and compliant regulatory submissions. You'll work closely with project teams, coordinating documents for submission to Regulatory Authorities and Ethics Committees. Staying up-to-date on regulations and providing insightful analysis to project teams will be a core part of your responsibilities.

What You'll Do 🎯

• Provide regulatory guidance throughout the clinical development lifecycle.
• Compile, coordinate, and review applications to Regulatory Authorities (CTA/IND, annual reports, amendments, etc.).
• Develop and review documents for submission to Regulatory Authorities and/or Ethics Committees.
• Represent Global Regulatory Affairs at project team meetings (internal and external).
• Lead projects (regionally or globally), as needed.
• Oversee and coordinate Regulatory Affairs Specialists to meet submission targets.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Assist in the development of Regulatory Affairs Specialists and other staff.
• Contribute to regulatory strategy and timeline development for new studies.
• Help establish company standards for high-quality submissions.
• Participate in corporate quality initiatives.
• Stay current on laws, regulations, and guidelines governing drug development.
• Provide ICH GCP guidance, advice, and training.
• Represent Global Regulatory Affairs at business development meetings.

What We're Looking For 💪

Minimum Requirements:

• Bachelor's degree (or equivalent experience) in a scientific or healthcare field.
• Manager: 5+ years of regulatory experience.
• Senior Manager: 7+ years of regulatory experience.
• Computer literacy (MS Office/Office 365).
• Fluent in English.

Preferred Qualifications:

• Graduate or postgraduate degree.
• Basic understanding of financial management.

Essential Skills & Experience:

• Regulatory affairs experience with a CRO, leading clinical submissions.
• Strong understanding of the drug development process and regulatory milestones.
• Specialized knowledge of regulatory activities in at least one major region (EU or US).
• Ability to interpret clinical and pre-clinical study results for regulatory strategy.
• Knowledge of clinical trial methodology, protocols, and indications.
• Expertise in relevant regulations and guidance for pharmaceutical development.
• Willingness to travel domestically and internationally.

Competencies ✨

• Excellent interpersonal skills and teamwork abilities.
• Professionalism, reliability, and positive interactions.
• Ability to manage multiple tasks in a fast-paced environment.
• High self-motivation and ability to work independently and in teams.
• Ability to motivate others to meet deadlines and goals.
• Flexibility and willingness to learn.
• Problem-solving skills and prioritization abilities.
• Focus on continuous improvement and process efficiency.
• High-quality data collection.
• Excellent written and verbal communication skills in English.
• Strong presentation skills to various audiences.

Additional Information ℹ️

• Location: Remote (UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland)
• Job Category: Healthcare

Apply Now! ➡️

Precision Medicine Group is an Equal Opportunity Employer. We value diversity and inclusion and encourage all qualified candidates to apply. For accommodation requests, contact QuestionForHR@precisionmedicinegrp.com. Beware of fraudulent job offers; we will only contact you through our official channels.