Regulatory Manager – Senior Regulatory Manager

🔥 0 minutes ago

🇷🇸 Serbia – 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 • Ensure timely preparation of organized, quality regulatory submissions in compliance with applicable regulations • 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 review documents for Regulatory Authorities and Ethics Committees • Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers • 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 • Provide input into regulatory strategy and timeline development for new study opportunities • Assist in establishing company standards for high-quality submitted information • Participate in corporate quality initiatives across Clinical Solutions business units • Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval • Provide ICH GCP guidance, advice, and training to internal and external clients

🎯 Requirements

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline • 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level • Informed knowledge of all aspects of the drug development process, including regulatory milestones • Specialized 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 with little management support • Ability to collect data of consistently high standard • Effective verbal and written communication in English • High proficiency conducting formal presentations to colleagues, investigative staff, and clients

🏖️ Benefits

• Employees feel appreciated for their contributions • Employee ideas are valued and nurtured • Equal opportunity employment • Reasonable accommodation support for applicants with disabilities