Regulatory Manager / Senior Regulatory Manager

About the role

Precision for Medicine, a global CRO focused on oncology and rare disease, is recruiting a Regulatory Manager or Senior Regulatory Manager depending on experience. The role provides regulatory strategy and development guidance for clinical trials, agency meetings, orphan designations, paediatric planning and accelerated procedures, and coordinates regulatory documents submitted to Regulatory Authorities and Ethics Committees.

Key responsibilities

• Provide regulatory guidance throughout the clinical development life cycle and compile, coordinate and review applications to Regulatory Authorities such as CTA/IND, annual reports, amendments, scientific advice, orphan designations, paediatric planning and marketing applications.
• Develop and review documents submitted to Regulatory Authorities and Ethics Committees to ensure compliance with regulatory standards.
• Represent Global Regulatory Affairs at project team meetings and business development meetings, and lead projects for the region or globally when needed.
• Oversee Regulatory Affairs Specialists to meet submission targets, maintain project plans, trackers and regulatory intelligence tools, and assist in developing specialists and other staff.
• Help set company standards, contribute to regulatory strategy and timelines, and take part in corporate quality initiatives.
• Keep up to date with laws, regulations and guidelines, give ICH GCP guidance and training, and be available for domestic and international travel including overnight stays.

Required profile

• 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.
• Regulatory affairs experience in a CRO or the pharmaceutical industry, including leading clinical submissions.
• Informed knowledge of the drug development process and regulatory activities in at least one major region (EU or US), including IND/CTA submissions, scientific advice and post-approval submissions.
• Ability to interpret clinical and pre-clinical study results and to work with domestic and international travel.
• Must be legally authorized to work in the country of employment without employer sponsorship.

Required skills

• Knowledge of clinical trials methodology, protocols and indications, and of regulations and guidance supporting pharmaceutical development.
• Strong communication in English, including formal presentations to colleagues, investigators and clients.
• Teamwork, multitasking in a fast-paced environment, record keeping, and independent initiative.