Regulatory Manager / Senior Regulatory Manager

🔥 4 minutes ago

🇭🇺 Hungary – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 19%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures • Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees • Provide regulatory guidance throughout the clinical development life cycle • Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications • Develop and/or review submission documents for regulatory compliance • Represent Global Regulatory Affairs at internal and external project team meetings • Work within project teams and lead regional or global projects when necessary • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintain project plans, trackers, and regulatory intelligence tools; update Regulatory Leadership • Assist in developing Regulatory Affairs Specialists and other operational staff • Contribute to regulatory strategy and timeline development for new study opportunities • Help establish company standards for high-quality submitted information • Participate in corporate quality initiatives across Clinical Solutions business units • Maintain knowledge of laws, regulations, and guidelines governing drug development and approval • Provide ICH GCP guidance, advice, and training to internal and external clients • Represent Global Regulatory Affairs at business development meetings

🎯 Requirements

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline • 5 years Regulatory experience required for the Manager level • 7 years Regulatory experience required for the Senior Manager Regulatory level • Informed knowledge of all aspects of the drug development process, including regulatory milestones • Specialised knowledge of regulatory activities for at least one major region (EU, US) • Experience with submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions • Regulatory affairs experience working for a CRO or within the Pharmaceutical Industry • Experience leading Clinical Submissions • Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy • Knowledge of clinical trials methodology, including 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 • Strong interpersonal skills and ability to contribute to a team environment • Understanding of financial management • Ability to manage multiple and varied tasks in a fast-moving environment • Good record-keeping skills • Ability to work and plan independently and in a team environment • Ability to resolve project-related problems and prioritize workload to meet deadlines • Ability to communicate effectively in English, verbally and in writing • Proficiency in formal presentations to colleagues, investigative staff, and clients

🏖️ Benefits

• Employees feel appreciated for their contributions • Input and ideas valued and nurtured, impacting positive change for the company • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities